MOVe-AHEAD: Study of MK-4482 for Prevention of Coronavirus Disease 2019 (COVID-19) in Adults (MK-4482-013)
Sponsor
Merck Sharp & Dohme LLC (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04939428
Collaborator
(none)
1,376
215
2
16
6.4
0.4
Study Details
Study Description
Brief Summary
The purpose of the study is to assess if the study medication (molnupiravir, MK-4482) will prevent symptomatic coronavirus disease 2019 (COVID-19) in adults who live with someone with confirmed COVID-19 infection. This is a phase 3, multicenter, randomized, double-blind, placebo-controlled study; half of the study participants will receive molnupiravir twice daily by mouth and the other half will receive a placebo. The primary objectives of the study are to determine if molnupiravir prevents symptomatic COVID-19 disease and to evaluate its safety and tolerability. All participants who develop COVID-19 during the study are still eligible for any COVID-19 treatment recommended by their doctor.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
1376 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of MK-4482 for the Prevention of COVID-19 (Laboratory-confirmed SARS-CoV-2 Infection With Symptoms) in Adults Residing With a Person With COVID-19
Actual Study Start Date
:
Aug 11, 2021
Anticipated Primary Completion Date
:
Dec 11, 2022
Anticipated Study Completion Date
:
Dec 11, 2022
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Molnupiravir Participants take molnupiravir 800 mg every 12 hours (Q12H) on Days 1 to 5. |
Drug: Molnupiravir
Four molnupiravir 200 mg capsules taken by mouth.
Other Names:
|
| Placebo Comparator: Placebo Participants take placebo Q12H on Days 1 to 5. |
Drug: Placebo
Placebo capsule matched to molnupiravir 200 mg capsules taken by mouth.
|
Outcome Measures
Primary Outcome Measures
- Percentage of participants who have undetectable SARS-CoV-2 in baseline nasopharyngeal (NP) swabs and develop COVID-19 (laboratory-confirmed SARS-CoV-2 infection with symptoms) through Day 14 [Up to Day 14]
Percentage of participants who have undetectable SARS-CoV-2 in baseline NP swabs and develop COVID-19 (laboratory-confirmed SARS-CoV-2) infection with symptoms) through Day 14.
- Percentage of participants with ≥1 adverse event [Up to 29 days]
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
- Percentage of participants discontinuing from study therapy due to AE [Up to 5 days]
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Secondary Outcome Measures
- Percentage of participants (regardless of SARS-CoV-2 in baseline NP swabs) who develop COVID-19 (laboratory-confirmed SARS-CoV-2 infection with symptoms) through Day 14 [Up to Day 14]
Participants who experience targeted symptoms of COVID-19 (e.g., cough, sore throat) will have NP swabs tested for SARS-CoV-2 using reverse-transcription polymerase chain reaction (RT-PCR).
- Percentage of participants who have undetectable SARS-CoV-2 in baseline NP swabs and develop COVID-19 (laboratory-confirmed SARS-CoV-2 infection with symptoms) through Day 29 [Up to Day 29]
Participants who experience targeted symptoms of COVID-19 (e.g., cough, sore throat) will have NP swabs tested for SARS-CoV-2 using RT-PCR.
- Percentage of participants who have undetectable SARS-CoV-2 in baseline NP swabs and develop detectable SARS-CoV-2 in NP swabs on or before Day 14 [Up to Day 14]
All participants will have NP swabs collected at screening and through Day 14 to test for SARS-CoV-2 using RT-PCR.
- Percentage of participants who have detectable SARS-CoV-2 in baseline NP swabs and develop COVID-19 (laboratory-confirmed SARS-CoV-2 infection with symptoms) through Day 14 [Up to Day 14]
Participants who experience targeted symptoms of COVID-19 (e.g., cough, sore throat) will have NP swabs tested for SARS-CoV-2 using RT-PCR.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
Lives in a household with an index case where the index case is a person with documented COVID-19 (laboratory-confirmed SARS-CoV-2 infection with symptoms case) and must have 1) a first detectable SARS-CoV-2 test result from a sample collected within ≤5 days prior to randomization of the participant, and 2) at least 1 symptom attributable to COVID-19 (e.g., fever, difficulty breathing)
-
Does not have confirmed or suspected COVID-19
-
Is willing and able to take oral medication
-
For males, agrees to be abstinent from penile-vaginal intercourse OR agrees to use a highly effective contraceptive method while receiving study drug and for ≥3 months after the last dose of study drug
-
Is female and not pregnant/breastfeeding and at least one of the following applies during the study and for ≥4 days after: is not a woman of childbearing potential (WOCBP), is a WOCBP and uses highly effective contraception (low user dependency method OR a user dependent hormonal method in combination with a barrier method), or is a WOCBP who is abstinent from heterosexual intercourse
Exclusion Criteria:
-
Has a prior history of laboratory-confirmed SARS-CoV-2 infection (with or without symptoms) within 6 months prior to randomization
-
Has either of the following: human immunodeficiency virus (HIV) with a recent viral load >50 copies/mL (regardless of CD4 count) or an acquired immunodeficiency syndrome (AIDS)-defining illness
-
Has a history of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection with any of the following: cirrhosis, end-stage liver disease, hepatocellular carcinoma; aspartate transaminase (AST) and/or (ALT) >3x upper limit of normal at screening
-
Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator
-
Has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments including but not limited to participants with conditions that could limit gastrointestinal absorption of capsule contents
-
Has received, is taking, or is anticipated to require any prohibited therapies
-
Has received a COVID-19 vaccination with the first dose ≥7 days prior to randomization
-
Is unwilling to abstain from participating in another interventional clinical study through Day 29 with an investigational compound or device, including those for COVID-19 therapeutics
-
Is living in a household with >10 people
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cahaba Research, Inc. ( Site 2523) | Birmingham | Alabama | United States | 35235 |
| 2 | The Institute for Liver Health DBA Arizona Clinical Trials ( Site 2484) | Mesa | Arizona | United States | 85210 |
| 3 | The Institute for Liver Health DBA Arizona Clinical Trials ( Site 2448) | Tucson | Arizona | United States | 85712 |
| 4 | Hope Clinical Research ( Site 2400) | Canoga Park | California | United States | 91303 |
| 5 | Carbon Health ( Site 2515) | Carlsbad | California | United States | 92009 |
| 6 | UCSF Fresno ( Site 2528) | Fresno | California | United States | 93701 |
| 7 | ASCADA Research, LLC ( Site 2516) | Fullerton | California | United States | 92835 |
| 8 | Marvel Clinical Research ( Site 2490) | Huntington Beach | California | United States | 92647 |
| 9 | National Research Institute ( Site 2452) | Los Angeles | California | United States | 90057 |
| 10 | Valley Clinical Trials Inc. ( Site 2406) | Northridge | California | United States | 91325 |
| 11 | Carbon Health ( Site 2514) | Oakland | California | United States | 94610 |
| 12 | University of California Davis ( Site 2497) | Sacramento | California | United States | 95817 |
| 13 | Millennium Clinical Trials ( Site 2468) | Simi Valley | California | United States | 93065 |
| 14 | Future Innovative Treatments, LLC ( Site 2471) | Colorado Springs | Colorado | United States | 80907 |
| 15 | Emerson Clinical Research Institute ( Site 2457) | Washington | District of Columbia | United States | 20011 |
| 16 | Synergy Healthcare ( Site 2521) | Bradenton | Florida | United States | 34208 |
| 17 | Accel Research Sites-DeLand Clinical Research Unit ( Site 2535) | DeLand | Florida | United States | 32720 |
| 18 | Velocity Clinical Research, Hallandale Beach ( Site 2485) | Hallandale Beach | Florida | United States | 33009 |
| 19 | Indago Research and Health Center Inc ( Site 2412) | Hialeah | Florida | United States | 33012 |
| 20 | Advanced Research For Health Improvement LLC ( Site 2436) | Immokalee | Florida | United States | 34142 |
| 21 | Clinical Site Partners, LLC d/b/a CSP Miami ( Site 2508) | Miami | Florida | United States | 33186 |
| 22 | Clinical Research Trials of Florida ( Site 2402) | Tampa | Florida | United States | 33607 |
| 23 | Clinical Site Partners, LLC d/b/a CSP Miami ( Site 2425) | Winter Park | Florida | United States | 32789 |
| 24 | Chicago Clinical Research Institute Inc ( Site 2454) | Chicago | Illinois | United States | 60607 |
| 25 | Rush University Medical Center ( Site 2510) | Chicago | Illinois | United States | 60612 |
| 26 | MedPharmics, LLC ( Site 2443) | Metairie | Louisiana | United States | 70006 |
| 27 | Institute of Human Virology ( Site 2504) | Baltimore | Maryland | United States | 21201 |
| 28 | Centennial Medical Group ( Site 2435) | Elkridge | Maryland | United States | 21075 |
| 29 | Jadestone Clinical Research, LLC ( Site 2530) | Silver Spring | Maryland | United States | 20904 |
| 30 | Michigan Center of Medical Research ( Site 2445) | Farmington Hills | Michigan | United States | 48334 |
| 31 | Michigan Center of Medical Research ( Site 2525) | Lathrup Village | Michigan | United States | 48076 |
| 32 | Allina Health Infectious Diseases Research Clinic ( Site 2507) | Minneapolis | Minnesota | United States | 55404 |
| 33 | University of Missouri Hospital ( Site 2486) | Columbia | Missouri | United States | 65212 |
| 34 | Mercury Street Medical Group PLLC ( Site 2476) | Butte | Montana | United States | 59701 |
| 35 | University of Nebraska Medical Center ( Site 2430) | Omaha | Nebraska | United States | 68198-3135 |
| 36 | Excel Clinical Research, LLC ( Site 2404) | Las Vegas | Nevada | United States | 89109 |
| 37 | ID Care ( Site 2466) | Hillsborough | New Jersey | United States | 08844 |
| 38 | Amici Clinical Research LLC ( Site 2426) | Raritan | New Jersey | United States | 08869 |
| 39 | AXCES Research Group ( Site 2437) | Santa Fe | New Mexico | United States | 87505 |
| 40 | Montefiore Medical Center ( Site 2503) | Bronx | New York | United States | 10462 |
| 41 | ECU Adult Specialty Care ( Site 2415) | Greenville | North Carolina | United States | 27834 |
| 42 | The Lindner Center for Research and Education at The Christ Hospital ( Site 2517) | Cincinnati | Ohio | United States | 45219 |
| 43 | Dayton Clinical Research ( Site 2488) | Dayton | Ohio | United States | 45406 |
| 44 | Cherokee Nation WW Hastings Indian Hospital/Cherokee Nation Health Services ( Site 2459) | Tahlequah | Oklahoma | United States | 74464 |
| 45 | Preferred Clinical Research ( Site 2470) | Pittsburgh | Pennsylvania | United States | 15236 |
| 46 | Velocity Clinical Research-Providence ( Site 2432) | East Greenwich | Rhode Island | United States | 02818 |
| 47 | Tribe Clinical Research, LLC ( Site 2409) | Greenville | South Carolina | United States | 29607 |
| 48 | TTS Research ( Site 2433) | Boerne | Texas | United States | 78006 |
| 49 | Houston Methodist Hospital ( Site 2463) | Houston | Texas | United States | 77030 |
| 50 | Santa Clara Family Clinic ( Site 2462) | Houston | Texas | United States | 77087 |
| 51 | Crossroads Clinical Research LLC ( Site 2451) | Victoria | Texas | United States | 77901 |
| 52 | TPMG Clinical Research ( Site 2495) | Williamsburg | Virginia | United States | 23188 |
| 53 | Covid-19 Clinical Research Center (CCRC) ( Site 2421) | Seattle | Washington | United States | 98109 |
| 54 | Sanatorio de la Trinidad Mitre ( Site 0108) | Caba | Buenos Aires | Argentina | C1039AAO |
| 55 | Mautalen Salud e Investigacion ( Site 0103) | Caba | Buenos Aires | Argentina | C1128AAF |
| 56 | Hospital Italiano de Buenos Aires ( Site 0102) | Caba | Buenos Aires | Argentina | C1199ABB |
| 57 | Instituto de Investigaciones Clínicas Mar del Plata ( Site 0105) | Mar del Plata | Buenos Aires | Argentina | B7600FZO |
| 58 | Clinica Independencia ( Site 0104) | Munro | Buenos Aires | Argentina | B1605FRE |
| 59 | Grupo Oroño Centro medico San Nicolas ( Site 0109) | San Nicolas | Buenos Aires | Argentina | B2900DPA |
| 60 | Instituto Medico de la Fundacion Estudios Clinicos ( Site 0106) | Rosario | Santa Fe | Argentina | 2000 |
| 61 | CEMIC ( Site 0101) | Buenos Aires | Argentina | C1431FWO | |
| 62 | Fundaçao de Medicina Tropical Doutor Heitor Vieira Dourado ( Site 0303) | Manaus | Amazonas | Brazil | 69040-000 |
| 63 | Faculdade de Medicina da Universidade Federal de Mato Grosso do Sul - UFMS ( Site 0305) | Campo Grande | Mato Grosso Do Sul | Brazil | 79070-900 |
| 64 | Hospital Nossa Senhora das Gracas ( Site 0310) | Curitiba | Parana | Brazil | 80810-040 |
| 65 | Oncosite-Centro de Pesquisa Clinica em Oncologia ( Site 0300) | Ijui | Rio Grande Do Sul | Brazil | 98700-000 |
| 66 | Centro de Referência e Treinamento DST/AIDS ( Site 0301) | Sao Paoulo | Sao Paulo | Brazil | 04121-000 |
| 67 | Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0312) | São José do Rio Preto | Sao Paulo | Brazil | 15090000 |
| 68 | Centro de Referencia Professor Helio Fraga - FIOCRUZ/RJ ( Site 0314) | Rio de Janeiro | Brazil | 22780-192 | |
| 69 | Medical Center Hera EOOD ( Site 3001) | Sofia | Sofia (stolitsa) | Bulgaria | 1510 |
| 70 | Medical Center Hera Kyustendi EOOD ( Site 3003) | Kyustendil | Bulgaria | 2500 | |
| 71 | Medical Center Hera EOOD - Montana branch ( Site 3002) | Montana | Bulgaria | 3400 | |
| 72 | Fundacion Centro de Investigacion Clinica CIC ( Site 0402) | Medellin | Antioquia | Colombia | 050021 |
| 73 | Centro Cientifico Asistencial Jose Luis Accini ( Site 0412) | Barranquilla | Atlantico | Colombia | 080020 |
| 74 | Clinica de la Costa Ltda. ( Site 0407) | Barranquilla | Atlantico | Colombia | 080020 |
| 75 | Oncomedica S.A. ( Site 0406) | Monteria | Cordoba | Colombia | 230002 |
| 76 | Hospital Universitario Clinica San Rafael ( Site 0410) | Bogota | Cundinamarca | Colombia | 110411 |
| 77 | Healthy Medical Center S.A.S ( Site 0413) | Zipaquira | Cundinamarca | Colombia | 250252 |
| 78 | Caja de Compensacion Familiar CAFAM ( Site 0403) | Bogota | Distrito Capital De Bogota | Colombia | 111211 |
| 79 | Fundacion Centro de Investigaciones Clinicas CARDIOMET ( Site 0409) | Pereira | Risaralda | Colombia | 660003 |
| 80 | Instituto Neumologico del Oriente S.A. ( Site 0408) | Bucaramanga | Santander | Colombia | 681004 |
| 81 | Fundacion Valle del Lili ( Site 0405) | Cali | Valle Del Cauca | Colombia | 760032 |
| 82 | Unidad de Aislamiento del Centro de Obstetricia y Ginecologia ( Site 2650) | Santo Domingo | Distrito Nacional | Dominican Republic | 10605 |
| 83 | National Center for allergies and chest ( Site 2940) | Giza | Al Jizah | Egypt | 12651 |
| 84 | Imbaba Fevers Hospital ( Site 2945) | Giza | Al Jizah | Egypt | 12661 |
| 85 | Masri - CRC - Ain Shams University ( Site 2900) | Cairo | Al Qahirah | Egypt | 11566 |
| 86 | Masri - CRC - Ain Shams University ( Site 2910) | Cairo | Al Qahirah | Egypt | 11566 |
| 87 | National Hepatology and Tropical Medicine Research Institute ( Site 2930) | Cairo | Al Qahirah | Egypt | 11796 |
| 88 | Air Force Specialized Hospital Clinical Research Center ( Site 2920) | Cairo | Al Qahirah | Egypt | 11835 |
| 89 | Maison de Sante Universitaire La Providence ( Site 0506) | Toulouse | Haute-Garonne | France | 31500 |
| 90 | Hôpital Pitié - Salpêtrière ( Site 0501) | Paris | Ile-de-France | France | 75013 |
| 91 | CHU de la Reunion - Groupe Hospitalier Sud ( Site 0508) | Saint Pierre Cedex | La Reunion | France | 97448 |
| 92 | CHU Martinique ( Site 0511) | Fort De France | Martinique | France | 97200 |
| 93 | Maison de santé du Pays Neufchatelois ( Site 0507) | Neufchatel-en-Bray | Seine-Maritime | France | 76270 |
| 94 | Centro de Investigaciones Pediatricas ( Site 0703) | Guatemala | Guatemala | 01001 | |
| 95 | Unidad de Diagnostico Cardiologico ( Site 0701) | Guatemala | Guatemala | 01001 | |
| 96 | Clínica Médica Especializada en Pediatría e Infectología Pediátrica - Dr. Mario Melgar ( Site 0702) | Guatemala | Guatemala | 01009 | |
| 97 | Clinica Privada ( Site 0705) | Guatemala | Guatemala | 01010 | |
| 98 | Private Clinic - Dr. Hugo Pezzarossi ( Site 0704) | Guatemala | Guatemala | 01015 | |
| 99 | LONA MEDIC Kft ( Site 0804) | Oroshaza | Bekes | Hungary | 5900 |
| 100 | Debreceni Egyetem Klinikai Kozpont- Infektologiai Klinika ( Site 0824) | Debrecen | Hajdu-Bihar | Hungary | 4031 |
| 101 | Bugat Pal Korhaz ( Site 0817) | Gyongyos | Heves | Hungary | 3200 |
| 102 | Medifarma-98 Kft. ( Site 0808) | Nyiregyhaza | Szabolcs-Szatmar-Bereg | Hungary | 4400 |
| 103 | DRC Gyogyszervizsgalo Kozpont Kft. ( Site 0801) | Balatonfured | Veszprem | Hungary | 8230 |
| 104 | Obudai Egeszsegugyi Centrum - OEC ( Site 0821) | Budapest | Hungary | 1036 | |
| 105 | Strazsahegy Medicina Bt ( Site 0823) | Budapest | Hungary | 1171 | |
| 106 | Obudai Egeszsegugyi Centrum - Zalaegerszeg ( Site 0819) | Zalaegerszeg | Hungary | 8900 | |
| 107 | IUHW Narita Hospital ( Site 1105) | Narita | Chiba | Japan | 286-8520 |
| 108 | National Hospital Organization Okinawa National Hospital ( Site 1109) | Ginowan | Okinawa | Japan | 901-2214 |
| 109 | Social Medical Corporation Yuuaikai Yuuai Medical Center ( Site 1108) | Tomigusuku | Okinawa | Japan | 901-0224 |
| 110 | Chiba Aoba Municipal Hospital ( Site 1100) | Chiba | Japan | 260-0852 | |
| 111 | Global Healthcare Clinic ( Site 1106) | Tokyo | Japan | 102-0083 | |
| 112 | Den-en-chofu family clinic ( Site 1104) | Tokyo | Japan | 145-0071 | |
| 113 | Center Hospital of the National Center for Global Health and Medicine ( Site 1101) | Tokyo | Japan | 162-8655 | |
| 114 | KEMRI-CMR-RCTP- Kenya Medical Research Institute Kisumu ( Site 1925) | Kisumu | Kenya | 40100 | |
| 115 | Hospital Raja Perempuan Zainab II ( Site 2851) | Kota Bharu | Kelantan | Malaysia | 15586 |
| 116 | Klinik Kesihatan Masjid Tanah ( Site 2850) | Masjid Tanah | Melaka | Malaysia | 78300 |
| 117 | Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 1308) | Ciudad de Mexico | Distrito Federal | Mexico | 14080 |
| 118 | Morales Vargas Centro de Investigacion, S.C. ( Site 1318) | Leon | Guanajuato | Mexico | 37000 |
| 119 | Hospital General de Acapulco ( Site 1319) | Acapulco | Guerrero | Mexico | 39570 |
| 120 | Instituto Jalisciense de Metabolismo SC ( Site 1314) | Guadalajara | Jalisco | Mexico | 44670 |
| 121 | Centro Médico Universitario ( Site 1316) | Cuernavaca | Morelos | Mexico | 62210 |
| 122 | CHRISTUS - LATAM HUB CENTER OF EXCELLENCE AND INNOVATION S.C. ( Site 1315) | Gral Escobedo | Nuevo Leon | Mexico | 66055 |
| 123 | Centro de Investigacion y Avances Medicos Especializados -CIAME ( Site 1301) | Cancun | Quintana Roo | Mexico | 77500 |
| 124 | Köhler & Milstein Research S.A. de C.V. ( Site 1300) | Merida | Yucatan | Mexico | 97070 |
| 125 | Centro de Investigacion Medica Aguascalientes ( Site 1305) | Aguascalientes | Mexico | 20116 | |
| 126 | ICARO Investigaciones en Medicina ( Site 1313) | Chihuahua | Mexico | 31000 | |
| 127 | Medica Sur S.A.B de C.V. ( Site 1303) | Mexico City | Mexico | 14050 | |
| 128 | Oaxaca Site Management Organization S.C. ( Site 1304) | Oaxaca | Mexico | 68000 | |
| 129 | Arké SMO S.A de C.V ( Site 1306) | Veracruz | Mexico | 91910 | |
| 130 | Policlínico Especializado en Neurología - Unid. Inv. Neurológica ( Site 1403) | La Perla | Qallaw | Peru | 07011 |
| 131 | Clínica Ricardo Palma ( Site 1406) | Lima | Peru | 15036 | |
| 132 | Asociacion Civil por la Salud ( Site 1411) | Lima | Peru | 15046 | |
| 133 | Investigaciones Medicas en Salud - INMENSA ( Site 1401) | Lima | Peru | 15046 | |
| 134 | Asociacion Civil IMPACTA Salud y Educacion - Sede San Miguel ( Site 1410) | Lima | Peru | 15088 | |
| 135 | Clinica Providencia ( Site 1400) | Lima | Peru | 15088 | |
| 136 | Instituto de Investigacion Nutricional - Anexo Huascar ( Site 1404) | Lima | Peru | 15423 | |
| 137 | Asian Hospital and Medical Center ( Site 1503) | Muntinlupa | National Capital Region | Philippines | 1780 |
| 138 | Quirino Memorial Medical Center ( Site 1501) | Quezon City | National Capital Region | Philippines | 1109 |
| 139 | Centrul Medical Unirea SRL Bucuresti ( Site 1706) | Bucaresti | Bucuresti | Romania | 011601 |
| 140 | Centrul Medical Unirea SRL ( Site 1707) | Cluj-Napoca | Cluj | Romania | 400349 |
| 141 | S.C Materna Care SRL ( Site 1702) | Timisoara | Timis | Romania | 300645 |
| 142 | Centrul Medical Unirea ( Site 1705) | Brasov | Romania | 500091 | |
| 143 | Delta Heath Care S.R.L ( Site 1708) | Bucuresti | Romania | 014142 | |
| 144 | SC Policlinica CCBR SRL. Bucuresti ( Site 1704) | Bucuresti | Romania | 030463 | |
| 145 | Centrul Medical Unirea SRL Constanta ( Site 1703) | Constanta | Romania | 900540 | |
| 146 | Centrul Medical Unirea SRL IASI ( Site 1701) | Iasi | Romania | 700023 | |
| 147 | FSBI Central Hospital with Policlinics ( Site 1807) | Moscow | Moskva | Russian Federation | 121359 |
| 148 | Infectious Clinical Hospital # 1 ( Site 1834) | Moscow | Moskva | Russian Federation | 125310 |
| 149 | SPb SBHI City outpatient clinic 112 ( Site 1829) | Saint Petersburg | Sankt-Peterburg | Russian Federation | 195427 |
| 150 | Smorodintsev Research Institute of Influenza ( Site 1833) | Saint Petersburg | Sankt-Peterburg | Russian Federation | 197376 |
| 151 | Nikolaevskaya hospital ( Site 1810) | Saint Petersburg | Sankt-Peterburg | Russian Federation | 198510 |
| 152 | SPb SBHI City outpatient clinic 4 ( Site 1831) | Saint Petersburg | Sankt-Peterburg | Russian Federation | 199406 |
| 153 | Limited liability company "Scientific research center Eco-safety" ( Site 1809) | Saint-Petersburg | Sankt-Peterburg | Russian Federation | 196143 |
| 154 | City Polyclinic #88 ( Site 1808) | Saint-Petersburg | Sankt-Peterburg | Russian Federation | 198261 |
| 155 | LLC -Medical Center . Capital-Polis ( Site 1825) | Saint-Petrsburg | Sankt-Peterburg | Russian Federation | 190013 |
| 156 | St.Petersburg Outpatient Clinic No. 109 ( Site 1818) | Saint-Petrsburg | Sankt-Peterburg | Russian Federation | 192289 |
| 157 | SPb SBHI. City outpatient clinic No.44 ( Site 1830) | St.Petersburg | Sankt-Peterburg | Russian Federation | 192071 |
| 158 | Medical Research Institute LLC. ( Site 1814) | St.Petersburg | Sankt-Peterburg | Russian Federation | 196084 |
| 159 | Smolensk State Medical University ( Site 1803) | Smolensk | Smolenskaya Oblast | Russian Federation | 214019 |
| 160 | Republican Clinical Infectious Hospital n.a. A.F. Agafonov ( Site 1802) | Kazan | Tatarstan, Respublika | Russian Federation | 420140 |
| 161 | Voronezh Regional Clinical Hospital #1 ( Site 1823) | Voronezh | Voronezskaja Oblast | Russian Federation | 394066 |
| 162 | LLC -Clinic of modern medicine of Doctor Bogorodskaya ( Site 1828) | Yaroslavl | Yaroslavskaya Oblast | Russian Federation | 150001 |
| 163 | IATROS International ( Site 1921) | Bloemfontein | Free State | South Africa | 9300 |
| 164 | REIMED Reiger Park ( Site 1910) | Boksburg | Gauteng | South Africa | 1459 |
| 165 | Midrand Medical Centre ( Site 1913) | Halfway House, Midrand | Gauteng | South Africa | 1685 |
| 166 | Wits Health Consortium. Clinical HIV Research Unit ( Site 1923) | Johannesburg | Gauteng | South Africa | 2041 |
| 167 | Right To Care Research - Esizayo ( Site 1907) | Johannesburg | Gauteng | South Africa | 2087 |
| 168 | DJW Navorsing ( Site 1915) | Krugersdorp | Gauteng | South Africa | 1739 |
| 169 | Mzansi Ethical Research Centre ( Site 1918) | Mpumalanga | Gauteng | South Africa | 1055 |
| 170 | Jongaie Research ( Site 1900) | Pretoria-West | Gauteng | South Africa | 0183 |
| 171 | Global Clinical Trial Centre ( Site 1904) | Pretoria | Gauteng | South Africa | 0186 |
| 172 | Dr Jugnundun & Partners ( Site 1905) | Durban | Kwazulu-Natal | South Africa | 4091 |
| 173 | Enhancing Care Foundation-DICRS ( Site 1922) | Durban | Kwazulu-Natal | South Africa | 4091 |
| 174 | Private Practice - Dr. Neyaseelan Gounden ( Site 1911) | Durban | Kwazulu-Natal | South Africa | 4093 |
| 175 | Limpopo Clinical Research Initiative ( Site 1901) | Thabazimbi | Limpopo | South Africa | 0380 |
| 176 | TASK Applied Science ( Site 1920) | Cape Town | Western Cape | South Africa | 7405 |
| 177 | DTHF Masiphumelele Clinical Research Site ( Site 1919) | Cape Town | Western Cape | South Africa | 7975 |
| 178 | Be Part Yoluntu Centre ( Site 1914) | Paarl | Western Cape | South Africa | 7626 |
| 179 | Paarl Research Centre ( Site 1924) | Paarl | Western Cape | South Africa | 7646 |
| 180 | Hospital Universitari Germans Trias i Pujol ( Site 2010) | Badalona | Barcelona | Spain | 08916 |
| 181 | CAP Centelles ( Site 2011) | Centelles | Barcelona | Spain | 08540 |
| 182 | Hospital de Alcorcon ( Site 2003) | Alcorcon | Madrid, Comunidad De | Spain | 28922 |
| 183 | C.S. Vallcarca-Sant Gervasi ( Site 2000) | Barcelona | Spain | 08023 | |
| 184 | CAP de Sardenya ( Site 2009) | Barcelona | Spain | 08025 | |
| 185 | Hospital Universitario Infanta Leonor ( Site 2002) | Madrid | Spain | 28031 | |
| 186 | Hospital Universitario La Paz ( Site 2024) | Madrid | Spain | 28046 | |
| 187 | HIV-NAT AIDS Research Centre ( Site 2804) | Bangkok | Krung Thep Maha Nakhon | Thailand | 10330 |
| 188 | Chulabhorn Hospital ( Site 2801) | Lak Si | Krung Thep Maha Nakhon | Thailand | 10210 |
| 189 | Rajavithi Hospital ( Site 2803) | Ratchathewi | Krung Thep Maha Nakhon | Thailand | 10400 |
| 190 | The Golden Jubilee Medical Center ( Site 2800) | Phutthamonthon | Nakhon Pathom | Thailand | 73170 |
| 191 | Songklanagarind Hospital ( Site 2802) | Hat-Yai | Songkhla | Thailand | 90110 |
| 192 | Atakent Acibadem Hastanesi ( Site 2103) | Halkali/K.cekmece | Istanbul | Turkey | 34303 |
| 193 | Sancaktepe Prof Dr Ilhan Varank EAH-Prof Dr Feriha Oz Hastanesi ( Site 2113) | Istabul | Istanbul | Turkey | 34785 |
| 194 | Ankara Universitesi Ibni Sina Hastanesi ( Site 2101) | Ankara | Turkey | 06230 | |
| 195 | Hacettepe Universitesi Tip Fakultesi ( Site 2102) | Ankara | Turkey | 06230 | |
| 196 | Gazi Universitesi Tip Fakultesi Hastanesi ( Site 2106) | Ankara | Turkey | 06560 | |
| 197 | Ankara Sehir Hastanesi ( Site 2111) | Ankara | Turkey | 06800 | |
| 198 | Istanbul Universitesi Istanbul Tip Fakultesi ( Site 2110) | Istanbul | Turkey | 34093 | |
| 199 | Medipol Universite Hastanesi ( Site 2108) | Istanbul | Turkey | 34214 | |
| 200 | Basaksehir Cam ve Sakura City Hospital ( Site 2112) | Istanbul | Turkey | 34494 | |
| 201 | Ege Universitesi Tip Fakultesi Hastanesi ( Site 2105) | Izmir | Turkey | 35100 | |
| 202 | Sakarya Universitesi Egitim ve Arastirma Hastanesi ( Site 2107) | Sakarya | Turkey | 54100 | |
| 203 | Ivano-Frankivsk Regional Clinical Infectious Diseases Hospital ( Site 2232) | Ivano-Frankivsk | Ivano-Frankivska Oblast | Ukraine | 76007 |
| 204 | Regional Phthisiopulmonological Center ( Site 2203) | Ivano-Frankivsk | Ivano-Frankivska Oblast | Ukraine | 76018 |
| 205 | NPME -Central Clinical Hospital of Ivano-Frankivsk City Council ( Site 2204) | Ivano-Frankivsk | Ivano-Frankivska Oblast | Ukraine | 76025 |
| 206 | Non profit municipal enterprise City hospital student of Kharkiv city council ( Site 2229) | Kharkiv | Kharkivska Oblast | Ukraine | 61002 |
| 207 | PCNE Kharkiv City polyclinic 9 of the Kharkiv City Council ( Site 2201) | Kharkiv | Kharkivska Oblast | Ukraine | 61172 |
| 208 | Limited Liability Company Medical center Healthy Happy ( Site 2225) | Kyiv | Kyivska Oblast | Ukraine | 01033 |
| 209 | MNPE Consultative-Diagnostic Centre of Desnyanskyi District of Kyiv ( Site 2205) | Kyiv | Kyivska Oblast | Ukraine | 02232 |
| 210 | Kyiv railway clinical hospital 2 of Branch Health center ( Site 2207) | Kyiv | Kyivska Oblast | Ukraine | 03049 |
| 211 | Municipal Noncommercial Enterprise Lviv 4th City Clinical Hospital ( Site 2200) | Lviv | Lvivska Oblast | Ukraine | 79011 |
| 212 | Odesa Regional Center of Socially Significant Diseases ( Site 2230) | Odesa | Odeska Oblast | Ukraine | 65014 |
| 213 | MNCE -Odesa regional clinical hospital of Odesa regional council ( Site 2226) | Odessa | Odeska Oblast | Ukraine | 65025 |
| 214 | Municipal Enterprise Poltava Regional Clinical Infectious Hospital ( Site 2227) | Poltava | Poltavska Oblast | Ukraine | 36011 |
| 215 | Medical Clinical Investigational Center of Medical Center Health Clinic ( Site 2210) | Vinnytsia | Vinnytska Oblast | Ukraine | 21009 |
Sponsors and Collaborators
- Merck Sharp & Dohme LLC
Investigators
- Study Director: Medical Director, Merck Sharp & Dohme LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier:
NCT04939428
Other Study ID Numbers:
- 4482-013
- MK-4482-013
- jRCT2031210281
- PHRR211007-003980
- 2021-000904-39
First Posted:
Jun 25, 2021
Last Update Posted:
Aug 12, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: