PROTECT Trial: A cluster-randomized study with hydroxychloroquine versus observational support for prevention or early-phase treatment of Coronavirus disease (COVID-19): A structured summary of a study protocol for a randomized controlled trial

Abstract

Objectives: Hydroxychloroquine has shown to have antiviral activity in vitro against coronaviruses, specifically SARS-CoV-2. It is believed to block virus infection by increasing endosomal pH required for virus cell fusion and glycosylation of viral surface proteins. In addition to its antiviral activity, hydroxychloroquine has an immune-modulating activity that may synergistically enhance its antiviral effect in vivo, making it a potentially promising drug for the prevention and the cure of SARS-CoV-19. However, randomized controlled trials are needed to assess whether it can be used safely to treat COVID-19 patients or to prevent infection. The main objective of the present study is to evaluate the efficacy of hydroxychloroquine for (I) the prevention of COVID-19 or related symptoms in SARS-CoV-2exposed subjects, such as as household members/contacts of COVID-19 patients and (II) the treatment of earlyphase asymptomatic or paucisymptomatic COVID-19 patients. Trial design: This is a controlled, open label, cluster-randomized, superiority trial with parallel group design. Subjects will be randomized either to receive hydroxychloroquine or to observation (2:1).

Sociodemographic characteristics and risk factors related to SARS-CoV-2 infection in Luanda, Angola

“…Community transmission and increased screening capacity for SARS-CoV-2 can help explain the growing number of infected and deaths related to COVID-19 in Angola. The same pattern has been noticed in the African region, mainly in South Africa, Ethiopia, Kenya, and Botswana which also have community transmission and notable increases in cases of infection and deaths related to COVID-19 [7]. According to the COVID-19 daily update bulletin from the Ministry of Health of Angola, the COVID-19 pandemic in Luanda was asymptomatic in the first three months with positive patients reporting no symptoms [25], however, as the pandemic progressed more cases were linked to symptoms such as cough (65.9%), fever (43.2%), headache (26.1%), shortness of breath (18.2%), malaise (17.0%), and sore throat (12.5%) (Table 3).…”

“…Currently, the world is facing a global pandemic of SARS-CoV-2, with many countries experiencing a second wave of infections [ 24 ]. In Angola, there is a continuous trend of an increase in the number of infections and deaths related to COVID-19 [ 7 , 25 ]. Community transmission and increased screening capacity for SARS-CoV-2 can help explain the growing number of infected and deaths related to COVID-19 in Angola.…”

“…Infected individuals may experience fever, dry cough, fatigue, shortness of breath, myalgia, diarrhea, and in severe cases, the SARS-CoV-2 infection causes viral pneumonia and leads to death [4][5][6]. By the end of October 2020, over 40 million infections and over a million deaths related to SARS-CoV-2 infection have been reported globally [7]. In Africa, the pandemic is increasing in the number of infections and deaths [7,8].…”

“…By the end of October 2020, over 40 million infections and over a million deaths related to SARS-CoV-2 infection have been reported globally [7]. In Africa, the pandemic is increasing in the number of infections and deaths [7,8]. a1111111111 a1111111111 a1111111111 a1111111111 a1111111111…”

“…The first cases of SARS-CoV-2 infection in Angola were detected in March 2020 at the Instituto Nacional de Investigação em Saúde (INIS), the national reference biomedical research institute located in Luanda, the capital city of Angola. By the end of October 2020, about 10 000 infections and 270 deaths related to SARS-CoV-2 infection had been reported [ 7 ]. At the beginning of the COVID-19 pandemic in Angola, the INIS was the only institution responsible for laboratory testing and surveillance of SARS-CoV-2 cases in the country.…”