COVID-19: A Study to Evaluate the Safety and Efficacy of C19-IG 20% in SARS-CoV-2 Infected Asymptomatic Ambulatory Outpatients
Study Details
Study Description
Brief Summary
The purpose of the study is to compare the efficacy of anti-COVID-19 immune globulin (human) 20% (C19-IG 20%) (2 doses) versus placebo with regard to the percentage of asymptomatic participants who remain asymptomatic, i.e., who do not develop symptomatic coronavirus disease 2019 (COVID-19) through Day 14 as per the protocol defined criteria.
Condition or Disease | Intervention/Treatment | Phase |
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|
Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: C19-IG 20% 1 g Participants will receive 1 gram (g) of C19-IG 20% subcutaneous (SC) infusion containing one syringe of 5 mL C19-IG 20% plus one syringe of 5 mL 0.9% sodium chloride on Day 1 in a double-blind manner. |
Biological: C19-IG 20%
Anti-COVID-19 Immune Globulin (Human) 20%
Drug: 0.9% Sodium chloride
C19-IG 20% matching placebo
|
Experimental: C19-IG 20% 2 g Participants will receive 2 g of C19-IG 20% SC infusion containing two syringes 5 mL each of C19-IG 20% on Day 1 in a double-blind manner. |
Biological: C19-IG 20%
Anti-COVID-19 Immune Globulin (Human) 20%
|
Placebo Comparator: Placebo Participants will receive C19-IG 20% matching placebo as SC infusion containing two syringes of 5 mL each sterile 0.9% sodium chloride injection on Day 1 in a double-blind manner. |
Drug: 0.9% Sodium chloride
C19-IG 20% matching placebo
|
Outcome Measures
Primary Outcome Measures
- Percentage of Asymptomatic Participants who Remain Asymptomatic, i.e., who do not Develop Symptomatic COVID-19 [Up to Day 14]
Secondary Outcome Measures
- Change from Baseline in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load (log10 copies/mL) [Day 1 to Day 7, and up to Day 14]
- Percentage of Participants who Remain in an Outpatient Setting and Maintain Peripheral Oxygen Saturation by Pulse Oximetry (SpO2) ≥94% on Room Air [Day 3, Day 7, and Day 14]
- Percentage of Participants Negative for SARS-CoV-2 by Polymerase Chain Reaction (PCR) [Up to Day 14, and up to Day 29]
- Time to Negative SARS-CoV-2 PCR [Baseline up to Day 29]
- Percentage of Participants who Require Oxygen (O2) Supplementation [Up to Day 29]
- Duration of Any Oxygen [Up to Day 29]
- Absolute Value Score on a 7-point Ordinal Scale [Day 1, Day 7, Day 14, and Day 29]
- Mean Change from Baseline in the 7-point Ordinal Scale [Day 1, Day 7, Day 14, and Day 29]
- Percentage of Participants in Each Severity Category of the 7-point Ordinal Scale [Day 1, Day 7, Day 14, and Day 29]
- Change from Baseline in National Early Warning Score (NEWS) [Day 1, Day 7, Day 14, and Day 29]
- Percentage of Participants who Require At Least One COVID-19 Related Medically Attended Visit for Management/Treatment of COVID-19 which may Occur in Any Setting [Up to Day 29]
- Percentage of Participants who Require Hospital Admission for Medical Care (Non-Quarantine Purposes) [Up to Day 29]
- Duration of Hospital Stay [Up to Day 29]
- Percentage of Participants who Require Intensive Care Unit (ICU) Admission or Initiation of ICU Level Care [Up to Day 29]
- Duration of ICU Stay [Up to Day 29]
- Percentage of Participants Requiring Invasive Mechanical Ventilation [Up to Day 29]
- Duration of Invasive Mechanical Ventilation [Up to Day 29]
- Number of Participants with All-Cause Mortality [Up to Day 29]
- Number of Participants with Critical COVID-19 Illness [Up to Day 29]
- Length of Time to Clinical Progression to Critical COVID-19 Illness [Up to Day 29]
- Time to COVID-19 Symptoms [Up to Day 14]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Ambulatory male or female outpatients ≥ 18 years of age who have laboratory-confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection as determined by qualitative PCR (reverse transcriptase (RT)-PCR), or other commercial or public health assay approved by regulatory authorities as a diagnostic test for COVID-19 (inclusive of SARS-CoV-2 antigen testing or other approved rapid testing platforms) in any specimen ≤ 5 days prior to randomized treatment.
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Asymptomatic with no constitutional COVID-19 illness (evident symptoms), specifically no fever, cough, shortness of breath, fatigue, anorexia, vomiting/diarrhea, headache that is unrelated to pre-existing conditions (example, migraine), sore throat that is unrelated to other pre-existing medical conditions (example, allergies, gastroesophageal reflux disease), myalgias, olfactory disorders unrelated with previous medical condition, or evidence of pneumonia at Screening.
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Pulse oximetry peripheral oxygen saturation (SpO2) (oxygen saturation) on room air > 94% (i.e., 95% to 100%) at Screening.
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National Early Warning Score (NEWS) ≤ 2 points at Screening.
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Subject provides informed consent (ICF) prior to initiation of any study procedures.
Exclusion Criteria:
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Subjects who are admitted to hospital or for whom hospital admission is being planned at the time of Screening.
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Subjects requiring any form of oxygen supplementation at Screening.
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Concurrent or planned treatment with other agents with actual or possible direct antiviral activity against SARS-CoV-2 including remdesivir.
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Prior, concurrent or planned treatment with monoclonal antibodies (mAbs) against SARS-CoV-2
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Have participated in a previous SARS-CoV-2 vaccine study OR outside of a study have received any SARS-CoV-2 vaccine of any kind.
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Have a history of convalescent COVID-19 plasma treatment at Screening.
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Fever (temperature ≥38.0° C [≥100.4° F]), measured orally, requirement for antipyretics to reduce temperature (administered for fever), and/or respiratory symptoms (cough, dyspnea) at Screening.
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Clinical evidence of any significant acute or chronic disease that, in the opinion of the investigator, may place the subject at undue medical risk for study treatment.
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The subject has had a known (documented) history of serious anaphylactic reaction to blood, any blood-derived plasma product or commercial immunoglobulin, or has known selective immunoglobulin A (IgA) deficiency with anti-IgA antibodies.
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Decompensated congestive heart failure or renal failure with fluid overload. This includes currently uncontrolled congestive heart failure New York Heart Association Class III or IV stage heart failure.
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Subjects for whom there is limitation of therapeutic effort such as "Do not resuscitate" status.
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Currently participating in another interventional clinical trial with investigational medical product or device.
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Subjects with known (documented) thrombotic complications to polyclonal intravenous immune globulin (IVIG) therapy in the past.
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Subject has medical condition (other than COVID-19) that is projected to limit lifespan to ≤ 1 year.
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Subject has history of drug or alcohol abuse within the past 12 months.
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Women who are pregnant or breastfeeding, or if of childbearing potential, unwilling to practice a highly effective method of contraception (oral, injectable, or implanted hormonal methods of contraception, placement of an intrauterine device or intrauterine system, condom, or occlusive cap with spermicidal foam/gel/cream/suppository, male sterilization, or true abstinence) throughout the study.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | CAP Gornal | L'Hospitalet de Llobregat | Barcelona | Spain | 08902 |
2 | CAP Navàs | Navàs | Barcelona | Spain | 08670 |
3 | CAP Sant Fèlix | Sabadell | Barcelona | Spain | 08024 |
4 | Centro de Salud Nuestra Señora del Pilar | Alcalá de Henares | Madrid | Spain | 28801 |
5 | Centro de Salud Presentación Sabio | Móstoles | Madrid | Spain | 28933 |
6 | CAP Manso | Barcelona | Spain | 08015 | |
7 | CAP Maluquer Salvador | Girona | Spain | 17002 | |
8 | Centro de Salud San Andrés | Madrid | Spain | 28021 | |
9 | Centro de Salud Fuentelarreina | Madrid | Spain | 28035 | |
10 | Centro de Salud Hacienda de Pavones Sureste | Madrid | Spain | 28108 | |
11 | Centro de Salud Isla de Oza Noroeste | Madrid | Spain | 28108 | |
12 | Hospital Sant Pau i Santa Tecla | Tarragona | Spain | 43003 |
Sponsors and Collaborators
- Grifols Therapeutics LLC
Investigators
- Principal Investigator: Oriol Mitjà, MD, omitja@flsida.org, +3493 4978339
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GC2010
- 2021-000269-34