Covid-19
Conditions
Interventions
Convalescent Plasma
Normal saline
Sponsors
Lagos State Government
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 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)
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. SARS-CoV-2 detectable in NP, OP or sputum samples at days 1, 3, 5, 7, 9, & 11. 2. Clinical status of subject at day 11 (on a 7-point ordinal scale) •Not hospitalized, no limitations on activities •Not hospitalized, limitation on activities •Hospitalized, not requiring supplemental oxygen •Hospitalized, requiring supplemental oxygen •Hospitalized, on non-invasive ventilation or high flow oxygen devices •Hospitalized, on invasive mechanical ventilation •Death. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Clinical status on Days 3, 5, 7, 9 & 11 2. Daily NEWS score until discharge or on Day 11 3. Duration of supplemental oxygen 4. Duration of mechanical ventilation 5. Duration of hospitalization 6. SARS-CoV-2 clearance time based on samples taken on Days 1, 3, 5, 7, 9, & 11 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 8. Cumulative incidence of treatment-related grade 3 and 4 adverse reactions (AR) during the study period up to and through Day 11 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) | — |
Countries
Nigeria
Contacts
Public ContactHussein AbdurRazzaq
Head Health Research
Outcome results
None listed