Assessment of Safety and Efficacy of CCP (COVIDIT)
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| ClinicalTrials.gov Identifier: NCT04542941 |
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Recruitment Status :
Completed
First Posted : September 9, 2020
Last Update Posted : January 15, 2021
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Currently there are no proven treatments or vaccines for COVID-19 and care of the COVID patients is largely supportive involving treatment of symptoms such as fever with antipyretics, secondary bacterial chest infection with antibiotics and meticulous management of comorbid conditions.
Several repurposed and new drugs have been investigated for treatment of COVID-19, however, none have been confirmed to be efficacious. These drugs include the antimalarials (chloroquine and hydroxychloroquine), antivirals such as remdesivir and favipiravir and antiretroviral combination therapies such lopinavir/ritonavir.
There is emerging evidence to support the use of COVID convalescent plasma for the treatment of COVID-19. There is need to leverage the blood transfusion services in countries and this is beginning to happen on the continent.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Covid19 | Biological: COVID Convalescent Plasma | Not Applicable |
Currently there are no proven treatments for COVID-19 and current standard therapy is supportive care with oxygen supplementation and treatment of symptoms. While treatments are being investigated in the Western world, it is likely that these data will take several months to become available and if proven to be efficacious, access in most of the low-income countries will be limited due to the high global demand and exorbitant costs.
In this study, the investigators aim to assess the safety and efficacy of use of CCP for treatment of adults with COVID-19 in Uganda.
The investigators hypothesise that administration of CCP to patients with positive SARS-CoV-2 RT PCR leads to earlier time to viral clearance compared to the standard of care.
Objectives:
General objective The overall objective of this project is to assess the safety and efficacy of COVID-19 convalescent plasma in the treatment of COVID-19 in Uganda.
Primary objective
1. To determine the efficacy of COVID-19 Convalescent Plasma, as measured by time to RT-PCR negativity of COVID-19 patients treated with COVID-19 Convalescent Plasma.
Secondary objectives
- To assess the safety of COVID-19 Convalescent Plasma in the treatment of COVID-19 patients in Uganda
- To document the time to symptom decrease of patients with positive SARS-CoV-2 RT PCR treated with CCP compared to those on standard of care
- To assess the ability of CCP therapy to stop progression to severe/critical forms of disease This study will be a prospective randomized two arm open label clinical trial. Patients with confirmed COVID-19 who meet the study eligibility criteria will be randomized to receive either CCP in addition to standard of care therapy or standard of care therapy alone.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 136 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | This study will be a prospective randomized two arm open label clinical trial. Patients with confirmed COVID-19 who meet the study eligibility criteria will be randomized to receive either CCP in addition to standard of care therapy or standard of care therapy alone. |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Assessment of Safety and Efficacy of COVID-19 Convalescent Plasma for Treatment of COVID-19 in Adults in Uganda; A Randomised Controlled Trial |
| Actual Study Start Date : | June 16, 2020 |
| Actual Primary Completion Date : | December 31, 2020 |
| Actual Study Completion Date : | December 31, 2020 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Intervention arm
The participants will receive COVID Convalescent Plasma in addition to the standard of care received by all COVID 19 patients
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Biological: COVID Convalescent Plasma
Plasma collected from recovered COVID 19 individuals |
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No Intervention: Control arm
The participants under this arm will receive the COVID 19 standard of care
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- Time to viral clearance (RT-PCR negativity) [ Time Frame: 28 days ]The primary end point will be time to viral clearance (RT-PCR negativity).
- Time to symptom resolution [ Time Frame: 28 days ]time to symptom resolution (resolution of the major COVID-19 symptoms of fever, cough, and shortness of breath, rhinorrhea and fatigue)
- Time to severe/critical disease [ Time Frame: 28 days ]Time to clinical improvement as evidenced by the modified ordinal scale for clinical improvement which has 8 states (not hospitalised and not on Oxygen therapy, hospitalised and on oxygen therapy, hospitalised no oxygen therapy, oxygen therapy by nasal prongs (<5l/min), oxygen therapy by mask, SFM or NRM (>10l/min), intubation and mechanical ventilation, ventilation plus additional organ support, death
- Number of participants reporting an adverse event as evidenced by clinical manifestations [ Time Frame: 28 days ]Safety of convalescent plasma as determined by clinical manifestations eg Skin or mucous membrane manifestations, respiratory compromise, Decrease in systolic blood pressure to <90 mmHg or >30% decrease from baseline or a diastolic drop of >30% from baseline, Tachycardia with an increase in resting heart rate to >130 bpm; or bradycardia <40 bpm that is associated with dizziness, nausea or feeling faint, Any other symptom which the good clinical judgment of the physician warrants halting the infusion (i.e., rapid onset of gastrointestinal symptoms, etc.)
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| Ages Eligible for Study: | 18 Years to 100 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Adults with documented laboratory RT PCR confirmed SAR-CoV-2 infection
- Patients able to provide informed consent. In the event that the patient cannot provide consent e.g. they are severely sick, the next of kin or legal surrogate decision make
Exclusion Criteria:
- Prior diagnosis of IgA deficiency
- Inability to return for post discharge follow up
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04542941
| Uganda | |
| Mulago Specialised Hospital | |
| Kampala, Uganda, 256 | |
| Responsible Party: | Makerere University |
| ClinicalTrials.gov Identifier: | NCT04542941 |
| Other Study ID Numbers: |
CCP |
| First Posted: | September 9, 2020 Key Record Dates |
| Last Update Posted: | January 15, 2021 |
| Last Verified: | January 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Plan Description: | Arrangments to enable sharing of de-identified data will be instituted by the research team. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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COVID-19 Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases |
Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases |