Lagos Covid-19 Convalescent Plasma Trial (LACCPT)

Authors
Category Primary study
Registry of TrialsPan African Clinical Trials Registry
Year 2020
INTERVENTION: Convalescent Plasma Normal saline CONDITION: ; Covid‐19 Covid‐19 PRIMARY OUTCOME: Percent of subjects with SARS‐CoV‐2 detectable in OP sampleat day 3, 5, 7, 9, and 11.; 1. Not hospitalized, no limitations on activities ; 2. Not hospitalized, limitation on activities ; 3. Hospitalized, not requiring supplemental oxygen ; 4. Hospitalized, requiring supplemental oxygen ; 5. Hospitalized, on non‐invasive ventilation or high flow oxygen devices.; 6. Hospitalized, on invasive mechanical ventilation ; 7. Death. ; SECONDARY OUTCOME: The time to discharge or to a NEWS of = 2 and maintained for 24 hours, ; whichever occurs first ; INCLUSION CRITERIA: 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 NP, OP swabs, and sputum 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 RT‐PCR, in any specimen < 72 hours prior to randomization. 6. Illness of any duration, and at least one of the following: • Radiographic infiltrates by imaging (chest x‐ray, CT scan), or • Clinical assessment (evidence of rales/crackles on exam) AND SpO2 = 94% on room air, or • Requiring mechanical ventilation and/or supplemental oxygen. 7. Women of childbearing potential must agree to use at least one primary form of contraception for the duration of the study (acceptable methods will be determined by the site
Epistemonikos ID: 1eceb6eccf0de46b4056c6088f9de9339c2c03c6
First added on: Jul 15, 2020