Lagos Covid-19 Convalescent Plasma Trial (LACCPT)

• Register: PACTR
• Last refreshed on: 29 May 2023
• Main ID: PACTR202006760881890
• Date of registration: 23/06/2020
• Prospective Registration: Yes
• Primary sponsor: Lagos State Government
• Public title: Lagos Covid-19 Convalescent Plasma Trial (LACCPT)
• Scientific title: A Multi-Center, Randomized, Double-Blind, Placebo- Controlled Clinical Trial of the Safety and Efficacy of Convalescent Plasma for the Treatment of COVID-19 in Hospitalized Patients in Lagos State
• Date of first enrolment: 01/08/2020
• Target sample size: 100
• Recruitment status: Recruiting
• URL: https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=12168
• Study type: Interventional
• Study design: Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously,Randomised,Simple randomization using a randomization table created by a computer software program,Sealed opaque envelopes
• Phase: Phase-2

Countries of recruitment

Nigeria

Contacts

• Name: Bodunrin Osikomaiya
• Affiliation: Executive Secretary

• Name: Hussein AbdurRazzaq
• Affiliation: Head Health Research

Key inclusion & exclusion 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 <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)
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

Age minimum: 19 Year(s)
Age maximum: 44 Year(s)
Gender: Both

Health Condition(s) or Problem(s) studied

Covid-19

Covid-19

Intervention(s)

Normal saline

Convalescent Plasma

Primary Outcome(s)

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 Outcome(s)

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)

Source(s) of Monetary Support

Lagos State Ministry of Health

Ethics review

Status: Approved
Approval date: 11/05/2020
Contact:

[e-mail]

LASUTH Health Research Ethics Committee

014710670

[e-mail]