ABSTRACT
Background: Viral rebound has been reported in people infected with COVID-19 treated with nirmatrelvir/ritonavir, and some cases been reported in patients who did not receive any antiviral treatment. Since the course of COVID-19 has not yet been well defined, we evaluated the incidence of viral rebound among COVID-19 patients treated with COVID-19 Convalescent Plasma (CCP) in Uganda. Methods: In the CCP trail, 136 patients were enrolled between 21st September 2020 and 2nd December 2020 who presented to the Mulago National Referral COVID-19 treatment unit. Patients with a positive SARS-CoV-2 reverse transcriptase (RT)-PCR test irrespective of disease severity were hospitalized and randomized to receive either COVID-19 CCP plus standard of care (SOC) or SOC alone. SARS-CoV-2 RT-PCR was done at baseline and on days 3, 5, 7, 14 and 28 post randomisation or until two consecutive negative RT-PCR results were obtained, whichever occurred first. We analysed for occurrence of viral rebound. Viral rebound was defined as a positive SARS-CoV-2 RT-PCR test following a prior negative test. Findings: 20% of the participants had viral rebound. Viral rebounders were predominantly male. The median age was 45-64 years and they had at least one co-morbidity. There was no difference in the rebound rates in the study arms, and participants with hypertension had more rebound rates compared to those with other co-morbidities. Interpretation: Viral RNA rebound was common among patients receiving CCP. Viral rebound may be a result of the biphasic nature of COVID-19 infection, and not a consequence of the therapeutic interventions.
Subject(s)
COVID-19 , HypertensionABSTRACT
Background: Community advisory structures such as Community Advisory Boards (CABs) play an important role of helping researchers to better understand the community at each phase of the clinical trial. CABs can be a source of accurate information on the community, its perception of proposed research and may identify factors that make community members vulnerable to the problem under investigation. Although CABs help to build mutually beneficial relationships between the researcher(s) and the communities in which the clinical trial is being implemented, meaningful engagement would require ethical guidance and regulatory oversight. The study assessed the stakeholders’ perspectives regarding the regulatory oversight of CABs in Uganda Methods: : This was a cross-sectional study employing qualitative methods of data collection and analysis. Key informant interviews (KIIs) with the trial investigators, CAB chairpersons, community liaison officers, regulators and REC chairpersons were conducted. A KII guide was designed and utilized during key informant interviews. The guide included questions on role of investigators and CAB members in clinical trials; challenges of community engagement; facilitation of CABs; regulatory oversight of CABs; work relationships between investigators and CABs; and opinions on how community trials should be conducted among others. All interviews were conducted in English. Qualitative data were transcribed verbatim. A code book was generated based on the transcripts and study objectives. Thematic analysis was used to analyze qualitative data in Atlas ti based on emerging themes and sub-themes and in line with the study objectives. Results: : Of the 34 respondents, 29.4% were investigators, 29.4% CAB chairpersons, 29.4% research regulators/REC Chairs and 11.8% community liaison officers. Fifty-nine percent were male and had varying occupations and demographic characteristics. Content analysis identified themes including the current practices for CAB establishment and monitoring; need for regulatory oversight; appropriate training and skills; and challenges faced by CABs. Conclusion: There is need for regulatory oversight of CABs based on contextualized ethical guidelines as well as capacity strengthening in terms of training and skills development.
Subject(s)
Communication DisordersABSTRACT
IntroductionEvidence that supports the use of COVID-19 convalescent plasma (CCP) for treatment of COVID-19 is increasingly emerging. However, very few African countries have undertaken the collection and processing of CCP. The aim of this study was to assess the feasibility of collecting and processing of CCP, in preparation for a randomized clinical trial of CCP for treatment of COVID-19 in Uganda. MethodsIn a cross-sectional study, persons with documented evidence of recovery from COVID-19 in Uganda were contacted and screened for blood donation via telephone calls. Those found eligible were asked to come to the blood donation centre for further screening and consent. Whole blood collection was undertaken from which plasma was processed. Plasma was tested for transfusion transmissible infections (TTIs) and anti-SARS CoV-2 antibody titers. SARS-CoV-2 testing was also done on nasopharyngeal swabs from the donors. Results192 participants were contacted of whom 179 (93.2%) were eligible to donate. Of the 179 eligible, 23 (12.8%) were not willing to donate and reasons given included: having no time 7(30.4%), fear of being retained at the COVID-19 treatment center 10 (43.5%), fear of stigma in the community 1 (4.3%), phobia for donating blood 1 (4.3%), religious issues 1 (4.4%), lack of interest 2 (8.7%) and transport challenges 1 (4.3%). The median age was 30 years and females accounted for 3.7% of the donors. A total of 30 (18.5%) donors tested positive for different TTIs. Antibody titer testing demonstrated titers of more than 1:320 for all the 72 samples tested. Age greater than 46 years and female gender were associated with higher titers though not statistically significant. ConclusionCCP collection and processing is possible in Uganda. However, concerns about stigma and lack of time, interest or transport need to be addressed in order to maximize donations.