Efficacy and Safety of African Medicinal plants in the treatment of mild or moderate COVID-19: a randomized clinical trial using Doubase C ® (preprint)

Introduction At the start of the COVID-19 pandemic, an herbal medicine Doubase C = Uvaria brevistipita + Haroungana madasgascariensis (DBC) had received authorization for clinical trials in DR Congo. We aimed to determine its efficacy and safety compared to hydroxychloroquine-azithromycin (HCQ-AZI), the national standard treatment for COVID-19 at that time. Methods We conducted an open randomized clinical trial between May 2021 and January 2022. Only mild and moderate cases of COVID-19 (WHO classification) were included. Asymptomatic, severe and critical cases were excluded. Each patient's parameters (NEW score, Ordinale scale, viral load, EKG tracing) were evaluated sequentially and the proportion of changes was compared between the two arms on days 7 and 14. Results 376 patients randomized (mean age = 40 years, 14 % ≥ 60 years, 90.7% mild case, 9.3% moderate case). From day 7, 97.6 % of mild case had a marked improvement in their NEW score and Ordinal scale (p=ns). Among patients with moderate case, 5.8% progressed to the severe form of COVID-19 in the HCQ-AZI arm and no patient in the DBC arm (p=ns). The viral load was progressively negative (29.8 % negative viral load on day 7 and 86.7 % on day 14) (p=ns). 4.4 % of patients on HCQ-AZI experienced QTc interval prolongation and none in the DBC arm (p=0.021). We have not recorded any critical cases or deaths. Conclusions In both arms, most patients experienced clinical improvement but DBC offers better cardiac safety. The young age of the patients may have influenced the results.

SARS-CoV2 mutations and impact on mortality: observational study in a sub- Saharan Africa hospital (preprint)

Background One year after the COVID-19 pandemic, the focus of attention has shifted to the emergence and spread of SARS-CoV-2 variants of concern (VOCs). The aim of the study was to assess the frequency of VOCs in patients followed for COVID-19 at Kinshasa university hospital (KUH) during the 3rd and 4th waves of the pandemic in Kinshasa. Hospital mortality was compared to that of the first two waves.Method The present study was conducted from June 2021 to January 2022 and included all patients in whom the diagnosis of SARS-CoV-2 infection was confirmed by the polymerase chain reaction (PCR). The laboratory team sequenced a subset of all SARS-CoV-2 positive samples with high viral loads define as Ct < 25 to ensure the chances to generate complete genome sequence. RNA extraction was performed using the Viral RNA Mini Kit (Qiagen). Depending on the platform, we used the iVar bioinformatics or artic environments to generate consensus genomes from the raw sequencing output in FASTQ format.Results During the study period, the original strain of the virus was no longer circulating. The Delta VOC was predominant from June (92%) until November 2021 (3rd wave). The Omicron VOC, which appeared in December 2021, became largely predominant one month later (96%) corresponding the 4th wave. In-hospital mortality associated with COVID-19 fell during the 2nd wave (7% vs 21% 1st wave), had risen during the 3rd (16%) wave before falling again during the 4th wave (7%) (p < 0.001).Conclusion The Delta (during the 3rd wave) and Omicron VOCs (during the 4th wave) were very predominant among patients followed for Covid-19 in our hospital. Contrary to data in the general population, hospital mortality associated with severe and critical forms of COVID-19 had increased during the 3rd wave of the pandemic in Kinshasa.

SARS-CoV2 infection in Symptomatic patients: interest of Serological tests and Predictors of Mortality. Experience of DR Congo (preprint)

Background: In symptomatic patients, the diagnostic approach of Covid-19 should be holistic. We aimed to evaluate the concordance between RT-PCR and serological tests (IgM/IgG), and identify the factors that best predict mortality (clinical stages or viral load).Methods: The study included 242 patients referred to the University hospital of Kinshasa for suspected Covid-19, dyspnea or ARDS between June 1st, 2020 and August 02, 2020. Both antibody-SARS-CoV2 IgM/IgG and RT-PCR method were performed on the day of admission to hospital. The clinical stages were established according to the Covid-19 WHO classification. The viral load was expressed by the CtN2 (cycle threshold value of the nucleoproteins) and the CtE (envelope) genes of SARS- CoV-2 detected using GeneXpert. Kappa test and Cox regression were used as appropriate.Results: The GeneXpert was positive in 74 patients (30.6%). Seventy two patients (29.8%) had positive IgM and 34 patients (14.0 %) had positive IgG. The combination of RT-PCR and serological tests made it possible to treat 104 patients as having Covid-19, which represented an increase in cases of around 41% compared to the result based on GeneXpert alone. The comparison between the two tests has shown that 57 patients (23.5 %) had discordant results. The Kappa coefficient was 0.451 (p <0.001). We recorded 23 deaths (22.1 %) among the Covid-19 patients vs 8 deaths (5.8 %) among other patients. The severe-critical clinical stage increased the risk of mortality vs. mild-moderate stage (aHR: 26.8, p < 0.001). The values ​​of CtE and CtN2 did not influence mortality significantly. Conclusion: in symptomatic patients, serological tests are a support which makes it possible to treat a greater number of Covid-19 patients. WHO Clinical classification seems to predict mortality better than SARS-Cov2 viral load.