Treatment of COVID-19 Cases and Chemoprophylaxis of Contacts as Prevention (HCQ4COV19)
Clara Health

Treatment of COVID-19 Cases and Chemoprophylaxis of Contacts as Prevention (HCQ4COV19)

Sponsored by Fundacio Lluita Contra la SIDA


The investigators plan to evaluate the efficacy of the 'test and treat' strategy of infected patients and prophylactic chloroquine treatment to all contacts. The strategy entails decentralized COVID-19 testing and starting antiviral darunavir/cobicistat plus chloroquine treatment immediately in all who are found to be infected. As viral loads decline to undetectable levels, the probability of onward transmission is reduced to very low levels. Such evaluation will require prospective surveillance to assess the population-level effect of transmission prevention.

Drug interventions in this protocol will follow the Spanish law about off-label use of medicines.

About 
COVID-19

Coronavirus disease 2019 (COVID-19) is a respiratory illness that can spread from person to person. The virus that causes COVID-19 is a novel coronavirus that was first identified during an investigation into an outbreak in Wuhan, China.

How is this study designed?

Study Type: Interventional (Clinical Trial) Estimated Enrollment: 3040 participants Primary Purpose: Prevention Official Title: Treatment of Non-severe Confirmed Cases of COVID-19 and Chemoprophylaxis of Their Contacts as Prevention Strategy: a Cluster Randomized Clinical Trial (PEP CoV-2 Study) Actual Study Start Date: March 18, 2020 Estimated Study Completion Date: June 15, 2020

Who is this study for?

Inclusion Criteria*:

  • Patients who meet the requirements of the New Coronavirus Infection Diagnosis (Acute respiratory infection symptoms or acute cough alone and positive PCR)
  • Aged ≥18 years male or female;
  • In women of childbearing potential, negative pregnancy test and commitment to use contraceptive method throughout the study.

Exclusion Criteria*:

  • Critically ill patients meeting one of the following: (1) Experience respiratory failure and need to receive mechanical ventilation; (2) Experience shock; (3) Complicated with other organs failure and need intensive care and therapy in ICU;

* Additional criteria apply. Please speak with the study team for further information.

What should I expect?

  • Lopinavir/ritonavir, a protease inhibitor used to treat HIV/AIDS, was found to block COVID-19 infection in vitro at low-micromolar concentration, with a half-maximal effective concentration (EC50) of 8.5 μM.
  • China's guidelines were set up in January 2020 and treated hospitalized patients with lopinavir/ritonavir, either alone or with various combinations. Darunavir (DRV)/Cobicistat, is also a protease inhibitor used to treat and prevent HIV/AIDS.
  • Its as effective as lopinavir/ritonavir for the treatment of HIV/AIDS and better tolerated because the adverse effects rate is lower (diarrhea 2% vs 27%).
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Have questions or need help?

For general questions about COVID-19 clinical trials, please email [email protected] For study specific inquiries, submit the interest form and you'll be connected to the team.