CUB-Erasme
" "Background: There are no currently approved therapeutics for COVID-19 disease. This disease causes significant morbidity and mortality. Main Objectives: The overall objective of the study is to evaluate the clinical efficacy and safety of different investigational therapeutics relative to the control arm in patients hospitalized with COVID-19 patients. The primary endpoint is subject clinical status (on a 7-point ordinal scale) on Day 15. The secondary objectives are to evaluate clinical, and virological efficacy, and safety of different investigational therapeutics as compared to the control arm. Study design: This is a prospective, worldwide, adaptive, randomized, controlled, open study comparing 4 different treatments for COVID-19. The protocol is based on the WHO Master protocol of the Solidarity trial. The DisCoVeRy protocol previews more data collection and lower dosage regimens of Hydroxychloroquine than in the SOLIDARITY trial. Randomization is performed by internet: patients are randomized in a 1:1:1:1:1 manner. The total number of patients to be included in the study is 3100 patients, over a 3 years period. Consenting, adults (age ≥18 years) recently hospitalized, or already hospitalized, with confirmed COVID-19 disease and, with no contra-indication to any of the study drugs will be randomly allocated between : • Local standard of care alone, OR • local standard of care plus one of: o Remdesivir (daily infusion for 10 days) o Hydroxychloroquine (400 mg twice daily on Day 1, followed by 400 mg once daily for 9 days) o Lopinavir with Ritonavir (orally twice daily for 14 days) o Lopinavir with Ritonavir (orally twice daily for 14 days) plus Interferon (daily injection on Day 1,3 and 6). Clinical, biological, radiological, genetic and virological data will be gathered and recorded. Pharmacokinetics of different investigational drugs will also be measured. Patients will be followed-up for 29 +/- 3 days." "
Funding: Special Projects COVID-19-ULB Submission made for FNRS funding
Publication References: "1. Marty FM, Vidal-Puigserver J, Clark C, Gupta SK, Merino E, Garot D, Chapman MJ, Jacobs F, Rodriguez-Noriega E, Husa P, Shortino D, Watson HA, Yates PJ, Peppercorn AF. Intravenous zanamivir or oral oseltamivir for hospitalized patients with influenza: an international, randomized, double-blind, double-dummy, phase-3 trial. Lancet Respir. Med. 2017. 5(2): 135-46. 2. Mitha E, Krivan G, Jacobs F, Nagler A, Alrabaa S, Mykietiuk A, Kenwright A, et al. Safety, resistance, and efficacy results from a phase IIIb study of conventional- and double dose oseltamivir regimens for treatment of influenza in immunocompromised patients. Infect Dis Ther. 2019. 8(4): 613-26. 3. Taccone FS, Laterre PF, Spspen H, Dugernier T, Delattre I, Layeux B, De Backer D, Wittebole X, Wallemacq P, Vincent JL, Jacobs F. Crit Care. 2010. 14(2): R53. Doi: 10.1186/cc8945. 4. Hites M, Deprez G, Wolff F, Ickx B, Verleije A, Closset J, Loi P, Prevost J, Taccone FS, Racapé J, Cotton F, Jacobs F. Evaluation of total body weight and body mass index cut-offs for increased cefazolin dose for surgical prophylaxis. Int J Antimicrob Agents. 2016. 48(6): 633-40. 5. Hites M, Taccone FS, Wolff F, Cotton F, Beumier M, De Backer D, Roisin S, Lorent S, Surin R, Seyler L, Vincent JL, Jacobs F. Case-control study of drug monitoring of ß-lactams in obese critically ill patients. Antimicrob Agents Chemother. 2013. 57(2): 708-715. "
Contact: Maya Hites Clinic of Infectious Diseases CUB-Erasme Route de Lennik, 808 1070 BXL Tel: +32.2.555.5779 e-mail: This email address is being protected from spambots. You need JavaScript enabled to view it.
Comment: I am not the promotor of this study. However, it is very important to participate in these international initiatives to identify as quickly as possible the best treatment options for patients hospitalized with COVID-19.