PACTR202006760881890.

Study name	Lagos COVID‐19 convalescent plasma trial (LACCPT)
Methods	Trial design: RCT Sample size: 100 Setting: Inpatient Country: Nigeria Language: English Number of centres: 6 Trial registration number: PACTR202006760881890 Date of registration: 24 June 2020
Participants	Inclusion criteria  Adults > 18 years  Moderate to severe COVID‐19 disease confirmed by PCR  Agrees to the collection of N‐P, OP swabs, sputum and venous blood per protocol. Illness of any duration, and at least one of the following: > 50% radiographic infiltrates by imaging (chest x‐ray, CT scan, etc.)   Clinical assessment (evidence of rales/crackles on exam) AND SpO2 ≤ 94% on room Requiring mechanical ventilation and/or supplemental oxygen.  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 ALT/AST > 5 times the upper limit of normal. Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR < 30) Pregnancy or lactation  Anticipated transfer to another hospital which is not a study site within 72 hours. Allergy to any study medication Donor eligibility criteria NR Donor exclusion criteria NR
Interventions	Intervention(s): CP therapy Details of CP: Type of plasma: CP Volume: 200 ml Number of doses: 2 Antibody‐titre: NR Pathogen inactivated: NR Treatment details, including time of plasma therapy (e.g. early stage of disease): NR Comparator: Saline with multivitamin Concomitant therapy: Standard care Treatment cross‐overs: nil
Outcomes	Primary study outcome: SARS‐CoV‐2 detectable in NP, OP or sputum samples at days 1, 3, 5, 7, 9, & 11.  Clinical status at day 11 (7 point ordinal scale) Primary review outcomes reported All‐cause mortality at hospital discharge: yes Time to death: NR Secondary review outcomes reported Number of participants with grade 3 and grade 4 AEs, including potential relationship between intervention and adverse reaction (e.g. TRALI, transfusion‐transmitted infection, TACO, TAD, acute transfusion reactions: Yes Number of participants with SAEs: Yes Improvement of clinical symptoms, assessed through need for respiratory support at up to 7 days; 8‐15 days; 16‐30 days: Yes 30‐day and 90‐day mortality: NR Admission on the ICU: NR Length of stay on the ICU: NR Time to discharge from hospital: NR QoL: NR Virological response: Yes Additional outcomes:  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)
Starting date	24 September 2020
Contact information	Full Name: Akin Abayomi Zip Code: NR City: Ikeja Address: Block 4, State Secretariat, Alausa Telephone: +2349031101982 Email: profakinabayomi@gmail.com
Notes	Recruitment status: Recruiting Prospective completion date: 30 November 2020 Sponsor/funding: Lagos State Government