Assessment of Safety and Efficacy of CCP
Condition: Covid19
MeSH terms: COVID-19
Study type: Interventional

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.
    

Intervention name(s): COVID Convalescent Plasma
Intervention type(s): Biological
Intervention description(s): Plasma collected from recovered COVID 19 individuals
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