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Assessment of Safety and Efficacy of CCP (COVIDIT)

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ClinicalTrials.gov Identifier: NCT04542941
Recruitment Status : Completed
First Posted : September 9, 2020
Last Update Posted : January 15, 2021
Sponsor:
Collaborators:
Uganda Blood Transfusion Services
Joint Clinical Research Center
Uganda Peoples Defence Forces Medical Services
Mulago Hospital, Uganda
Information provided by (Responsible Party):
Makerere University

Tracking Information
First Submitted Date  ICMJE August 31, 2020
First Posted Date  ICMJE September 9, 2020
Last Update Posted Date January 15, 2021
Actual Study Start Date  ICMJE June 16, 2020
Actual Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 7, 2020)
Time to viral clearance (RT-PCR negativity) [ Time Frame: 28 days ]
The primary end point will be time to viral clearance (RT-PCR negativity).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 13, 2021)
  • 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.)
Original Secondary Outcome Measures  ICMJE
 (submitted: September 7, 2020)
  • 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)
  • 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.)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessment of Safety and Efficacy of CCP
Official Title  ICMJE Assessment of Safety and Efficacy of COVID-19 Convalescent Plasma for Treatment of COVID-19 in Adults in Uganda; A Randomised Controlled Trial
Brief Summary

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.

Detailed Description

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

  1. To assess the safety of COVID-19 Convalescent Plasma in the treatment of COVID-19 patients in Uganda
  2. 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
  3. 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Covid19
Intervention  ICMJE Biological: COVID Convalescent Plasma
Plasma collected from recovered COVID 19 individuals
Study Arms  ICMJE
  • Active Comparator: Intervention arm
    The participants will receive COVID Convalescent Plasma in addition to the standard of care received by all COVID 19 patients
    Intervention: Biological: COVID Convalescent Plasma
  • No Intervention: Control arm
    The participants under this arm will receive the COVID 19 standard of care
Publications * Kirenga B, Byakika-Kibwika P, Muttamba W, Kayongo A, Loryndah NO, Mugenyi L, Kiwanuka N, Lusiba J, Atukunda A, Mugume R, Ssali F, Ddungu H, Katagira W, Sekibira R, Kityo C, Kyeyune D, Acana S, Aanyu-Tukamuhebwa H, Kabweru W, Nakwagala F, Bagaya BS, Kimuli I, Nantanda R, Buregyeya E, Byarugaba B, Olaro C, Mwebesa H, Joloba ML, Siddharthan T, Bazeyo W. Efficacy of convalescent plasma for treatment of COVID-19 in Uganda. BMJ Open Respir Res. 2021 Aug;8(1). pii: e001017. doi: 10.1136/bmjresp-2021-001017.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 7, 2020)
136
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 31, 2020
Actual Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Uganda
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04542941
Other Study ID Numbers  ICMJE CCP
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Arrangments to enable sharing of de-identified data will be instituted by the research team.
Responsible Party Makerere University
Study Sponsor  ICMJE Makerere University
Collaborators  ICMJE
  • Uganda Blood Transfusion Services
  • Joint Clinical Research Center
  • Uganda Peoples Defence Forces Medical Services
  • Mulago Hospital, Uganda
Investigators  ICMJE Not Provided
PRS Account Makerere University
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP