Clinical trial NCT04542941: Assessment of Safety and Efficacy of CCP
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Lead sponsor: Makerere University
Sponsor class: OTHER
Collaborators: name: Uganda Blood Transfusion Services
name: Joint Clinical Research Center
name: Uganda Peoples Defence Forces Medical Services
name: Mulago Hospital, Uganda
First posted: 2020-09-09
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Time to viral clearance (RT-PCR negativity)
timeFrame: 28 days
Secondary outcomes:
measure: Time to symptom resolution
timeFrame: 28 days
measure: Time to severe/critical disease
timeFrame: 28 days
measure: Number of participants reporting an adverse event as evidenced by clinical manifestations
timeFrame: 28 days
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Mulago Specialised Hospital
Study officials:
References:
citation: 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):e001017. doi: 10.1136/bmjresp-2021-001017.