Assessment of Safety and Efficacy of CCP

Covid19 Clinical Trial

— COVIDIT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04542941
• Other study ID #: CCP
• Status: Completed
• Phase: N/A
• Start date: June 16, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: January 2021
• Source: Makerere University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Covid19

Intervention

Biological:
• COVID Convalescent Plasma
Plasma collected from recovered COVID 19 individuals

Locations

Country	Name	City	State
Uganda	Mulago Specialised Hospital	Kampala

Sponsors (5)

Lead Sponsor	Collaborator
Makerere University	Joint Clinical Research Center, Mulago Hospital, Uganda, Uganda Blood Transfusion Services, Uganda Peoples Defence Forces Medical Services

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to viral clearance (RT-PCR negativity)	The primary end point will be time to viral clearance (RT-PCR negativity).	28 days
Secondary	Time to symptom resolution	time to symptom resolution (resolution of the major COVID-19 symptoms of fever, cough, and shortness of breath, rhinorrhea and fatigue)	28 days
Secondary	Time to severe/critical disease	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	28 days
Secondary	Number of participants reporting an adverse event as evidenced by clinical manifestations	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.)	28 days