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Age group |
24/06/2020 |
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Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s), Aged: 65+ Year(s) |
Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s), Aged: 65+ Year(s), 80 and over: 80+ Year |
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Official scientific title |
24/06/2020 |
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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
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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
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Funding Source |
FundingSources List |
24/06/2020 |
Reviewer's comment. |
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Lagos State Ministry of Health, State Secretariat, Alausa, Ikeja, 23401, Nigeria, Government Body, |
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Trial description |
24/09/2020 |
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The study is a multi-center trial that will be conducted at the Lagos State Isolation Centers, Nigeria with a single Sponsor. The design was adapted to the World Health Organization Master Protocol for Investigational Therapeutics for the Treatment of COVID-19 in Hospitalized Patients.
The study will compare a single investigational therapeutic agent (convalescent plasma) to a placebo, with both arms receiving standard supportive therapy. There will be interim monitoring to allow early stopping for futility, efficacy, or safety and to introduce new therapies as they become available. If one therapy proves to be superior to others in the trial, this treatment will then become the control arm for comparison(s) with new experimental treatment(s).
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This randomized, double-blind, placebo-controlled clinical trial will evaluate the efficacy and safety of Convalescent Plasma for the Treatment of COVID-19 in
Hospitalized Patients in Lagos State: All study subjects will receive standard therapy with the following add-ons: Arm 1 – convalescent plasma infusion; Arm 2 – placebo infusion.
A total of approximately 100 eligible subjects stratified 50:50 by the study sites of enrolment will be randomized in a 1:1 ratio to receive either convalescent plasma or placebo infusion.
All research participants will be assessed for the following:
• Clinical measures of safety and efficacy: Day 0 (baseline) to Day 11.
• Serum antibody titre to SARS-CoV-2: Day (-1 or 0), 5, 8, 11, and 29
• SARS-CoV-2 RNA levels in fluid from nasopharyngeal or oropharyngeal swabs: Day (-1 or 0), 3, 5, 7, 9, & 11. |
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Trial phase |
24/09/2020 |
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Phase-3 |
Phase-2 |
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Anticipated date of last follow up |
24/09/2020 |
Delayed commencement |
30 Sep 2020 |
30 Nov 2020 |
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Study Design |
Allocation sequence |
24/09/2020 |
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Simple randomization using a randomization table created by a computer software program |
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Actual trial start date |
24/09/2020 |
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14 Sep 2020 |
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Recruitment status |
24/09/2020 |
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Not yet recruiting |
Recruiting |
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Intervention |
Intervention List |
24/09/2020 |
Updated protocol |
Control Group, Normal saline, 200ml x 2, 1 day, Straw-coloured infusion, 50, Placebo |
Control Group, Normal saline, 200ml x 2, 1 day, Infusion of 0.5% normal saline with a straw-coloured agent (vitamin B-complex/ multivitamin) stored at room temperature, 50, Placebo |
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Eligibility |
Inclusion criteria |
24/09/2020 |
Updated protocol |
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). |
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) |
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Outcome |
OutCome List |
24/09/2020 |
Updated protocol |
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.
, Day 3, 5, 7, 9, and 11. |
Primary Outcome, 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., Day 3, 5, 7, 9, and 11. |
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OutCome List |
24/09/2020 |
Updated protocol |
Secondary Outcome, The time to discharge or to a NEWS of ≤ 2 and maintained for 24 hours,
whichever occurs first
, Daily while hospitalized and on day 15 |
Secondary Outcome, 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), Days 3, 5, 7, 9 11 |