Сlinical Trial of Efficacy and Safety of Prospekta in the Treatment of Post-COVID-19 Asthenia.

Sponsor
Materia Medica Holding (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05074888
Collaborator
(none)
680
Enrollment
43
Locations
2
Arms
38.5
Anticipated Duration (Months)
15.8
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The multicenter, double-blind, placebo-controlled, parallel-group, randomized clinical trial.

The objective of this study is to evaluate the efficacy and safety of Prospekta in the treatment of asthenia in patients after the coronavirus infectious disease (COVID-19).

Condition or DiseaseIntervention/TreatmentPhase
Phase 3

Detailed Description

Design: the multicenter, double-blind, placebo-controlled, parallel-group, randomized clinical trial.

The study will enroll adult patients of either gender aged 18 to 65 years after new coronavirus infection of 2019 (COVID-19) with symptoms of asthenia that appeared during or after an acute coronavirus infection (COVID-19) and persisting 4 to 12 weeks from the onset of coronavirus infection.

After the patient signs the patient information sheet and the informed consent form for participation in the study, complaints, medical history, physical examination, registration of vital signs are collected, the patient fills in the Fatigue Severity Scale (FSS) and Hospital Anxiety and Depression Scale (HADS). A six-minute walk test (6MWT) is carried out. The physician evaluates the severity of asthenia with FSS scale and records concomitant medications, co-morbidities and concurrent conditions.

If a patient meets all inclusion criteria and does not have any of the exclusion criteria at Visit 1 (Day 1), he/she is randomized to one of two groups: Group 1 - patients receive Prospekta at a dose of 1 tablet twice daily for 4 weeks; Group 2 - patients receive placebo on the study drug regimen.

The trial will use electronic patient diaries (EPD). The patient should record any possible deterioration (if applicable) in the EPD. At Visit 1 (Day 1), the physician will provide guidance on how to work with EPD, so that the patient can use it independently in the future.

At Visit 2 (Week 4 ± 3 days), the physician will collect patient's complaints, record physical examination data and vital signs as well as any changes in concurrent diseases and conditions. The patient fills out the FSS and HADS scales. A 6MWT is carried out. The physician monitors the prescribed treatment and use of concomitant medications, evaluates the safety of the study treatment and patient's compliance, filling out the diary.

The patient stops taking the study drug. At the end of the study treatment period, the patient is monitored for 4 weeks (follow-up period).

At Visit 3 (final visit, Week 8 ± 3 days), the physician collects patient's complaints, records physical examination data and vital signs, changes in concomitant diseases and conditions. The patient fills in the FSS and HADS scales. A 6MWT is carried out. The physician evaluates the safety of the study treatment, checks the completion of the diary.

During the study the patients are allowed to take medications for their chronic conditions, except for medicines listed as "Prohibited concomitant treatment".

Study Design

Study Type:
Interventional
Anticipated Enrollment :
680 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
double-blind, placebo-controlled, parallel-group, randomizeddouble-blind, placebo-controlled, parallel-group, randomized
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Multicenter, Double-blind, Placebo-controlled, Parallel-group, Randomized Clinical Trial of Efficacy and Safety of Prospekta in the Treatment of Patients With Post-COVID-19 Asthenia.
Actual Study Start Date :
Oct 15, 2021
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

ArmIntervention/Treatment
Experimental: Prospekta

Tablet for oral use. 1 tablet twice daily. The tablets are taken outside of meals (between meals or 15 minutes before eating or drinking), keep the tablets in the mouth, without swallowing, until completely dissolved.

Drug: Prospekta
Oral administration.

Placebo Comparator: Placebo

Tablet for oral use. Placebo using Prospekta scheme.

Drug: Placebo
Oral administration.

Outcome Measures

Primary Outcome Measures

  1. Change in the mean FSS score. [after 4 weeks of treatment]

    Fatigue Severity Scale (FSS). Change in the mean FSS score after 4 weeks of treatment. Based on medical records.1 indicates "strongly disagree" and 7 indicates "strongly agree."

Secondary Outcome Measures

  1. Change in distance of the 6-minute walk test. [after 4 weeks of treatment]

    Change in distance when performing the 6-minute walk test after 4 weeks of treatment. The test is carried out with the aim of objectively assessing the patient's physical tolerance. The patient should walk the maximum possible distance for himself at his own pace on a flat surface in 6 minutes.

  2. Change in the severity of anxiety and depression on the HADS subscales. [after 4 weeks of treatment]

    Hospital Anxiety and Depression Scale (HADS). Change in the severity of anxiety and depression on the HADS subscales after 4 weeks of treatment. The scale is composed of 14 statements serving 2 subscales: "anxiety" (odd items - 1, 3, 5, 7, 9, 11, 13) and "depression" (even items - 2, 4, 6, 8, 10, 12 , 14). Each statement corresponds to 4 answer options, reflecting the gradation of the severity of the sign and coded according to the increase in the severity of the symptom from 0 (no) to 3 (maximum severity). When interpreting the results, the total indicator for each subscale is taken into account, while there are 3 areas of its values: 0-7 - "norm" (absence of reliably expressed symptoms of anxiety and depression); 8-10 - "subclinical anxiety / depression"; 11 and above - "clinical anxiety / depression".

  3. Change in the mean FSS score within follow-up period. [within 4 weeks of follow-up]

    Change in mean FSS score over 4 weeks of follow-up period at the end of treatment.

  4. Change in distance of the 6-minute walk test within follow-up period. [within 4 weeks of follow-up]

    Change in distance when performing the 6-minute walk test over a 4-week follow-up period at the end of treatment.

  5. Change in the severity of anxiety and depression on the HADS subscales within follow-up period. [within 4 weeks of follow-up]

    Change in the severity of anxiety and depression on the HADS subscales over a 4-week follow-up period at the end of treatment.

  6. Changes in vital signs (pulse rate (heart rate)). [Changes in vital signs aafter 4 weeks of treatment and within 4 weeks of the follow-up period at the end of the treatment.]

    Based on medical records. Vital signs will be measured in a medical setting.

  7. Changes in vital signs (respiration rate (breathing rate)). [Changes in vital signs aafter 4 weeks of treatment and within 4 weeks of the follow-up period at the end of the treatment.]

    Based on medical records. Vital signs will be measured in a medical setting.

  8. Changes in vital signs (blood pressure). [Changes in vital signs aafter 4 weeks of treatment and within 4 weeks of the follow-up period at the end of the treatment.]

    Based on medical records. Vital signs will be measured in a medical setting.

  9. The presence and nature of of adverse events (AEs). [4 weeks of treatment and within 4 weeks of follow-up]

    The presence and nature of adverse events, their intensity (severity), causal relationship to the study drug, outcome. Based on medical records.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Adults of either gender aged 18 to 65 years inclusive.

  2. Patients within 4-12 weeks of the confirmed COVID-19 onset .

  3. Symptoms of asthenia that appeared during or after an acute new coronavirus infection (COVID-19), persisting from 4 to 12 weeks from the onset of coronavirus infection.

  4. Presence of asthenia (≥36 on the FSS scale).

  5. Patients who agreed to use a reliable method of contraception during the study (for men and women with reproductive potential).

  6. Presence of a signed information sheet and informed consent form for participation in a clinical trial.

Exclusion Criteria:
  1. History / suspicion of cancer of any localization (with the exception of benign neoplasms).

  2. More than 75% of lung tissue damage during the period of COVID-19 disease (CT 4).

  3. Cerebrovascular diseases with the development of moderate to severe cognitive impairments.

  4. Uncontrolled arterial hypertension characterized by the following blood tension values: systolic blood pressure > 180 mm Hg and/or diastolic blood pressure > 110 mm Hg.

  5. Myocardial infarction, stroke in the previous 6 months.

  6. Nervous system disorders with persistent neurological impairment.

  7. Autoimmune diseases.

  8. Decompensated diseases of the cardiovascular system, liver, kidney, gastrointestinal tract, and metabolic, respiratory, endocrine or hematological diseases, peripheral vascular disorders.

  9. Any severe comorbidity which, in the opinion of the investigator, may affect patient participation in the clinical trial.

  10. Hypersensitivity to any of the components of the study drug.

  11. Hereditary lactose intolerance, lactose malabsorption, including congenital or acquired lactase or other disaccharidase deficiency, galactosemia.

  12. Pregnancy, breast-feeding; childbirth less than 3 months prior to the inclusion in the trial, unwillingness to use contraceptive methods during the trial (for men and women with reproductive potential).

  13. Patients, who, from the investigator's point of view, will not comply with study observation requirements or study drug administration procedures..

  14. Prior history of mental illness, alcoholism or drug abuse, that the investigator's opinion, will interfere with successful study procedures.

  15. Use of any medications listed in "Prohibited concomitant treatment" within 1 week before enrollment.

  16. Participation in other clinical studies within 3 months prior to enrollment in the study.

  17. Patients who are related to any of the on-site research personnel directly involved in the conduct of the trial or are an immediate relative of the study investigator. "Immediate relative" means husband, wife, parent, son, daughter, brother, or sister (regardless of whether they are natural or adopted).

  18. Participants who work for OOO "NPF "MATERIA MEDICA HOLDING" (i.e. the company's employees, temporary contract workers, designated officials responsible for carrying out the research or any immediate relatives of the aforementioned).

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Belgorod Regional Clinical Hospital of St. JoasaphBelgorodRussian Federation308007
2Clinical hospital "RZD-Medicine" of Chelyabinsk cityChelyabinskRussian Federation454000
3LLC "Family Clinic"EkaterinburgRussian Federation620109
4Central city hospital # 7EkaterinburgRussian Federation620137
5Ivanovo clinical hospital named after Kuvaevs/Polyclinic #10IvanovoRussian Federation153025
6Clinical hospital "RZD-Medicine" in IvanovoIvanovoRussian Federation153043
7City Clinical Hospital # 9 of the Ministry of Health of the Udmurt RepublicIzhevskRussian Federation426063
8Kazan State Medical University, Department of Propedeutics of Internal Diseases named after prof. S.S. ZimnitskyKazanRussian Federation420012
9Kazan State Medical UniversityKazanRussian Federation420012
10Kirov State Medical University, Hospital Therapy DepartmentKirovRussian Federation610027
11LLC "Family polyclinic number 4"KorolevRussian Federation141060
12Kuban State Medical University, Infectious Diseases and PhthisiopulmonologyKrasnodarRussian Federation350063
13Krasnogorsk city hospital #r 1KrasnogorskRussian Federation143408
14City Clinical Hospital named after V.M. Buyanov of the Moscow City Health DepartmentMoscowRussian Federation115516
15Central Clinical Hospital of the Russian Academy of SciencesMoscowRussian Federation117593
16Llc "Verum Medical"MoscowRussian Federation119285
17City Clinical Hospital named after S.P. Botkin of the Moscow Department of HealthMoscowRussian Federation125284
18Moscow State Medical and Dental University named after A.I. Evdokimov, Department of Faculty Therapy and Occupational DiseasesMoscowRussian Federation127473
19Nizhny Novgorod Research Institute of Hygiene and Occupational PathologyNizhny NovgorodRussian Federation603005
20Clinical hospital "RZD-Medicine" in Nizhny Novgorod cityNizhny NovgorodRussian Federation603140
21Llc "Nizhmedklinika"Nizhny NovgorodRussian Federation603159
22Pyatigorsk City Clinical Hospital # 2PyatigorskRussian Federation357538
23City Emergency Hospital of Rostov-on-DonRostov-on-DonRussian Federation344068
24Ryazan State Medical University named after acad. I.P. Pavlov, Department of Outpatient Therapy and Preventive MedicineRyazanRussian Federation390026
25Llc "Ava-Peter"Saint PetersburgRussian Federation191014
26LLC "Energy of Health"Saint PetersburgRussian Federation194156
27Leningrad Regional Clinical HospitalSaint PetersburgRussian Federation194291
28LLC Medical center" Reavita Med SPb "Saint PetersburgRussian Federation194354
29City polyclinic # 51Saint PetersburgRussian Federation196211
30First Saint Petersburg State Medical University named after I.P. PavlovSaint PetersburgRussian Federation197022
31City Polyclinic # 34Saint PetersburgRussian Federation197198
32City Polyclinic # 43Saint PetersburgRussian Federation198207
33Samara City Hospital # 4SamaraRussian Federation443056
34Saratov State Medical University named after V. I. Razumovsky, Neurology Department named after K.N. TretyakovSaratovRussian Federation410012
35Saratov City Clinical Hospital # 5SaratovRussian Federation410071
36LLC "Scientific Medical Center for General Therapy and Pharmacology"StavropolRussian Federation355000
37Bashkir State Medical University, Internal Medicine DepartmentUfaRussian Federation450008
38Ulyanovsk Regional Clinical HospitalUlyanovskRussian Federation432063
39Volgograd State Medical University, Department of Neurology, Neurosurgery with the Course of Medical GeneticsVolgogradRussian Federation400131
40Vsevolozhsk clinical interdistrict hospitalVsevolozhskRussian Federation188643
41LLC "Center for Medical Consulting and Research - PRACTICE"YaroslavlRussian Federation150003
42Clinical Hospital # 2YaroslavlRussian Federation150030
43Clinical Hospital # 9YaroslavlRussian Federation150042

Sponsors and Collaborators

  • Materia Medica Holding

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Materia Medica Holding
ClinicalTrials.gov Identifier:
NCT05074888
Other Study ID Numbers:
  • MMH-MAP-006
First Posted:
Oct 12, 2021
Last Update Posted:
Nov 29, 2021
Last Verified:
Nov 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 29, 2021