Treatment of COVID-19 Cases and Chemoprophylaxis of Contacts as Prevention

NCT04304053 | Completed Phase 3 DMC

• 2 other identifiers: HCQ4COV192020-001031-27
• Study Type: interventional
• Target: 2,300
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a research project to evaluate the efficacy of hydroxychloroquine for post-exposure prophylaxis and early treatment of Covid-19. The intervention entails administering prophylactic hydroxychloroquine to all contacts (Study 1) and treating non severe confirmed cases with hydroxychloroquine (Study 2).

Conditions

COVID-19

Outcome Measures

Primary Outcomes (4)

• Study 1- Clinical and virological outcome in exposed contacts

  Incidence of secondary PCR confirmed symptomatic Covid-19 episodes among contacts after high risk PCR+ exposure

  Up to 14 days after start of treatment

• Study 1- Transmission of SARS-CoV-2 in exposed contacts

  Incidence of symptomatically compatible or a PCR-positive result regardless of symptoms

  Up to 14 days after start of treatment

• Study 2- Virological outcome in index cases

  Reduction of viral RNA load in nasopharyngeal swabs at days 3, and 7 after treatment start.

  Up to 7 days after start of treatment

• Study 2- Clinical outcome in index cases

  Time from randomization to complete resolution of symptoms at an extended 28-days follow-

  Up to 28 days after start of treatment

Study Arms (2)

No Intervention- SARS-CoV-2 surveillance

ACTIVE COMPARATOR

Study 1- Contacts will complete a survey collecting demographic, epidemiological and clinical data and provides a swab for RT-PCR testing at baseline and day 14. Study 2- Index case completes a survey collecting demographic, epidemiological and clinical data and provides a swab for RT-PCR testing at baseline and on days 3 and 7. Isolation of patient and contact tracing as per national guidelines.

Other: Standard Public Health measures

Testing, treatment and prophylaxis of SARS-CoV-2

EXPERIMENTAL

Study 1- Contacts receive Hydroxychloroquine prophylaxis. Contacts will complete a survey collecting demographic, epidemiological and clinical and provides a swab for RT-PCR testing at baseline and day 14. Study 2- Index case receives Hydroxychloroquine. Index case completes a survey collecting demographic, epidemiological and clinical data and provides a swab for RT-PCR testing at baseline and on days 3, and 7. Isolation of patient and contact tracing as per national guidelines.

Drug: Treatment and prophylaxis; Other: Standard Public Health measures

Interventions

Treatment and prophylaxis DRUG

Cases will be offered a therapeutic regimen hydroxychloroquine (200mg tablets) 800mg on day 1, and 400mg on days 2-7 Contacts will be offered a prophylactic regimen of hydroxychloroquine (200mg tablets) 800mg on day 1, and 400mg on days 2-7.

Testing, treatment and prophylaxis of SARS-CoV-2

Standard Public Health measures OTHER

Isolation of patient and contact tracing as per national guidelines.

No Intervention- SARS-CoV-2 surveillance; Testing, treatment and prophylaxis of SARS-CoV-2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Asymptomatic individuals exposed to a PCR confirmed COVID19 case within 7 days as either a healthcare worker or household contact
• Aged ≥18 years male or female;
• In women of childbearing potential, negative pregnancy test and commitment to use contraceptive method throughout the study.
• Willing to take study medication;
• Willing to comply with all study procedures;
• Able to provide oral, informed consent and/or assent.

You may not qualify if:

• With known history of cardiac arrhythmia (or QT prolongation syndrome);
• Unable to take drugs by mouth;
• With significantly abnormal liver function (Child Pugh C)
• Need of dialysis treatment, or GFR≤30 mL/min/1.73 m2;
• Participants with psoriasis, myasthenia, haematopoietic and retinal diseases,CNS-related hearing loss or glucose-6-phosphate dehydrogenase deficit;
• Persons already treated with any of the study drugs during the last 30 days;
• Pregnant or lactating women;
• Any contraindications as per the Data Sheet of Hydroxychloroquine.
• Study 2:
• Patients who meet the requirements of the New Coronavirus Infection Diagnosis (Acute \<5 days respiratory infection symptoms, or fever alone, 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.
• Willing to take study medication
• Willing to comply with all study procedures, including repeat nasal swab at day 3
• Able to provide oral and written informed consent

Sponsors & Collaborators

• Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia: lead
• Germans Trias i Pujol Hospital: collaborator
• Department of Health, Generalitat de Catalunya: collaborator
• Laboratorios Gebro Pharma SA: collaborator
• Laboratorios Rubió: collaborator
• Institut Catala de Salut: collaborator

Study Sites (1)

Departament de Salut

Barcelona, Spain

Location

Related Publications (2)

• Akhtar S, Das JK, Ismail T, Wahid M, Saeed W, Bhutta ZA. Nutritional perspectives for the prevention and mitigation of COVID-19. Nutr Rev. 2021 Feb 11;79(3):289-300. doi: 10.1093/nutrit/nuaa063.

  PMID: 33570583 DERIVED

• Mitja O, Corbacho-Monne M, Ubals M, Alemany A, Suner C, Tebe C, Tobias A, Penafiel J, Ballana E, Perez CA, Admella P, Riera-Marti N, Laporte P, Mitja J, Clua M, Bertran L, Sarquella M, Gavilan S, Ara J, Argimon JM, Cuatrecasas G, Canadas P, Elizalde-Torrent A, Fabregat R, Farre M, Forcada A, Flores-Mateo G, Lopez C, Muntada E, Nadal N, Narejos S, Nieto A, Prat N, Puig J, Quinones C, Ramirez-Viaplana F, Reyes-Uruena J, Riveira-Munoz E, Ruiz L, Sanz S, Sentis A, Sierra A, Velasco C, Vivanco-Hidalgo RM, Zamora J, Casabona J, Vall-Mayans M, Gonzalez-Beiras C, Clotet B; BCN-PEP-CoV2 Research Group. A Cluster-Randomized Trial of Hydroxychloroquine for Prevention of Covid-19. N Engl J Med. 2021 Feb 4;384(5):417-427. doi: 10.1056/NEJMoa2021801. Epub 2020 Nov 24.

  PMID: 33289973 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open label
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof (Ass) Infectious Disease and Global Health

Model Details: Primary study: Cluster-randomized clinical trial of Covid-19 contacts Secondary study: Randomized clinical trial of Covid-19 cases

Study Record Dates

• First Submitted: March 5, 2020
• First Posted: March 11, 2020
• Study Start: March 18, 2020
• Primary Completion: June 15, 2020
• Study Completion: June 15, 2020
• Last Updated: June 30, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 30 days after start of treatment
• Access Criteria: Open access for everybody

Locations

ES (1)