agos Covid-19 Convalescent Plasma Trial (LACCPT)
- Conditions
- Covid-19
- Registration Number
- PACTR202006760881890
- Lead Sponsor
- agos State Government
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
A. Moderate to Severe COVID-19 disease cases
1. Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures.
2. Understands and agrees to comply with planned study procedures.
3. Agrees to the collection of N-P, OP swabs, sputum and venous blood per protocol.
4. Male or non-pregnant female adult =18 years of age at time of enrolment.
5. Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay in any specimen <7 days prior to randomization.
6. Illness of any duration, and at least one of the following: > 50% radiographic infiltrates by imaging (chest x-ray, CT scan, etc.) OR Clinical assessment (evidence of rales/crackles on exam) AND SpO2 = 94% on room air OR requiring mechanical ventilation and/or supplemental oxygen.
7. If female of childbearing age, should agree to use at least one primary form of contraception for the duration of the study (acceptable methods will be determined by the site)
1.ALT/AST > 5 times the upper limit of normal.
2.Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR < 30)
3.Pregnancy or breast feeding.
4.Anticipated transfer to another hospital which is not a study site within 72 hours.
5.Allergy to any study medication
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. SARS-CoV-2 detectable in NP, OP or sputum samples at days 1, 3, 5, 7, 9, & 11.<br>2. Clinical status of subject at day 11 (on a 7-point ordinal scale)<br>•Not hospitalized, no limitations on activities <br>•Not hospitalized, limitation on activities <br>•Hospitalized, not requiring supplemental oxygen <br>•Hospitalized, requiring supplemental oxygen <br>•Hospitalized, on non-invasive ventilation or high flow oxygen devices <br>•Hospitalized, on invasive mechanical ventilation <br>•Death.
- Secondary Outcome Measures
Name Time Method 1. Clinical status on Days 3, 5, 7, 9 & 11 <br>2. Daily NEWS score until discharge or on Day 11 <br>3. Duration of supplemental oxygen <br>4. Duration of mechanical ventilation <br>5. Duration of hospitalization <br>6. SARS-CoV-2 clearance time based on samples taken on Days 1, 3, 5, 7, 9, & 11 <br>7. Cumulative incidence of treatment-related serious adverse reactions (SAR) categorized separately as either severe infusion reactions or Acute Respiratory Distress Syndrome (ARDS) during the study period<br>8. Cumulative incidence of treatment-related grade 3 and 4 adverse reactions (AR) during the study period up to and through Day 11 <br>9. Changes in laboratory safety indices assessed on Days 1, 5, & 11 (except for D-dimer which will be assessed on days 1, 3, 5, 7, & 11)