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Assessment of Safety and Efficacy of CCP (COVIDIT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04542941
Recruitment Status : Active, not recruiting
First Posted : September 9, 2020
Last Update Posted : September 9, 2020
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

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.


Condition or disease Intervention/treatment Phase
Covid19 Biological: COVID Convalescent Plasma Not Applicable

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.

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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
Estimated Primary Completion Date : October 31, 2020
Estimated Study Completion Date : October 31, 2020

Arm Intervention/treatment
Active Comparator: Intervention arm
The participants will receive COVID Convalescent Plasma in addition to the standard of care received by all COVID 19 patients
Biological: COVID Convalescent Plasma
Plasma collected from recovered COVID 19 individuals

No Intervention: Control arm
The participants under this arm will receive the COVID 19 standard of care



Primary Outcome Measures :
  1. Time to viral clearance (RT-PCR negativity) [ Time Frame: 28 days ]
    The primary end point will be time to viral clearance (RT-PCR negativity).


Secondary Outcome Measures :
  1. 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)

  2. 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.)



Information from the National Library of Medicine

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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
Criteria

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

Information from the National Library of Medicine

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


Locations
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Uganda
Mulago Specialised Hospital
Kampala, Uganda, 256
Sponsors and Collaborators
Makerere University
Uganda Blood Transfusion Services
Joint Clinical Research Center
Uganda Peoples Defence Forces Medical Services
Mulago Hospital, Uganda
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Responsible Party: Makerere University
ClinicalTrials.gov Identifier: NCT04542941    
Other Study ID Numbers: CCP
First Posted: September 9, 2020    Key Record Dates
Last Update Posted: September 9, 2020
Last Verified: September 2020
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No