Hydroxychloroquine Efficacy and Safety in Preventing SARS-CoV-2 Infection and COVID-19 Disease Severity During Pregnancy and Postpartum

NCT04410562 | Completed Phase 3 DMC

• 1 other identifier: 2020-001587-29
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 9

Brief Summary

It still unclear how SARS-CoV-2 affects pregnant women and their offspring, as well as which factors may influence obstetrical disease and outcomes, including the timing of maternal viral exposure by gestational age, the effects of parity, age, host immune responses, coexisting medical and obstetrical conditions and the effects of treatment regimens. While further information is gathered, based on the existing evidence from other infections causing pneumonia, pregnant women should be considered to be at high risk for developing severe infection during the current COVID-19 epidemic. Results from clinical trials with HCQ in nonpregnant adults may not be directly extrapolated to pregnant women given the special features of the pregnancy status. Thus, clinical research is urgently needed to improve the care and reduce the risk of poor pregnancy outcomes of women in this and in future epidemics.

Conditions

Pregnancy Related; COVID; Covid-19

Keywords

pregnancy; covid-19; coronavirus; hydroxychloroquine

Outcome Measures

Primary Outcomes (1)

• Number of PCR confirmed cases among pregnant women

  Number of PCR-confirmed infected pregnant women assessed from collected nasopharyngeal and oropharyngeal swabs at day 21 after treatment start

  21 days after intervention

Secondary Outcomes (20)

• Incidence of COVID-19 disease during pregnancy

  through study completion, an average of 1 year

• Incidence of COVID-19-related admissions

  through study completion, an average of 1 year

• Incidence of all-cause admissions

  through study completion, an average of 1 year

• Incidence of all-cause outpatient attendances

  through study completion, an average of 1 year

• Mean duration of symptoms-signs of COVID-19

  through study completion, an average of 1 year

Study Arms (2)

Hydroxychloroquine

EXPERIMENTAL

Participants will be then randomized in a 1:1 ratio to HCQ (400 mg/day for three days, followed by 200 mg/day for 11 days)

Drug: Hydroxychloroquine

Placebo

PLACEBO COMPARATOR

Participants will be then randomized in a 1:1 ratio to placebo (2 tablets for three days, followed by one tablet for 11 days).

Drug: Placebo

Interventions

Hydroxychloroquine DRUG

Participants will receive a bottle containing 19 tablets of study medication. They will be instructed to take two tablets for the first three days and one tablet for the following 11 days. (400 mg/day for three days, followed by 200 mg/day for 11 days).

Also known as: Dolquine

Hydroxychloroquine

Placebo DRUG

Participants will receive a bottle containing 19 tablets of placebo. They will be instructed to take two tablets for the first three days and one tablet for the following 11 days.

Placebo

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Presenting with fever (≥37.5ºC) and/or one mild symptom suggestive of COVID-19 disease (cough, dyspnoea, chills, odynophagia, diarrhoea, muscle pain, anosmia, taste disorder, headache) OR contact of a SARS-CoV-2 confirmed or suspected case in the past 14 days
• More than 12 weeks of gestation (dated by ultrasonography)
• Agreement to deliver in the study hospitals

You may not qualify if:

• Known hypersensitivity to HCQ or other 4-aminoquinoline compounds
• History of retinopathy of any aetiology
• Concomitant use of digoxin, cyclosporine, cimetidine
• Known liver disease
• Clinical history of cardiac pathology including known long QT syndrome
• Unable to cooperate with the requirements of the study
• Participating in other intervention studies
• Delivery onset (characterized by painful uterine contractions and variable changes of the cervix, including some degree of effacement and slower progression of dilatation up to 5 cm for first and subsequent labours)

Sponsors & Collaborators

• Barcelona Institute for Global Health: lead
• Hospital Clinic of Barcelona: collaborator
• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: collaborator
• University Hospital of Torrejon: collaborator
• Fundación de investigación HM: collaborator
• Hospital Sant Joan de Deu: collaborator
• Hospital del Mar: collaborator
• Hospital Universitario Infanta Leonor: collaborator
• Hospital Universitario Fundación Alcorcón: collaborator
• Hospital General de Segovia: collaborator
• Institut Català de la Salut: collaborator

Study Sites (9)

Hospital General de Segovia

Segovia, Cartilla Y León, 40002, Spain

Location

Hospital del Mar

Barcelona, Catalonia, 08003, Spain

Location

Hospital Clínic de Barcelona

Barcelona, Catalonia, 08036, Spain

Location

Hospital de la Sant Creu i Sant Pau

Barcelona, Catalonia, 08041, Spain

Location

Hospital Sant Joan de Déu

Esplugues de Llobregat, Catalonia, 08950, Spain

Location

Hospital Universitario Fundación Alcorcón

Alcorcón, Madrid, 28922, Spain

Location

HM Puerta del Sur

Móstoles, Madrid, 28938, Spain

Location

Hospital Universitario de Torrejón

Torrejón de Ardoz, Madrid, 28850, Spain

Location

Hospital Universitario Infanta Leonor

Madrid, 28031, Spain

Location

Related Publications (2)

• Gonzalez R, Gonce A, Gil MDM, Mazarico E, Ferriols-Perez E, Toro P, Llurba E, Saez E, Rodriguez-Zambrano MA, Garcia-Otero L, Lopez M, Santacruz B, Roman MA, Paya A, Alonso S, Cruz-Lemini M, Pons-Duran C, Herrera LB, Chen H, Bardaji A, Quinto L, Menendez C; COVID-Preg research group. Efficacy and safety of hydroxychloroquine for treatment of mild SARS-CoV-2 infection and prevention of COVID-19 severity in pregnant and postpartum women: A randomized, double-blind, placebo-controlled trial. Acta Obstet Gynecol Scand. 2024 Mar;103(3):602-610. doi: 10.1111/aogs.14745. Epub 2023 Dec 14.

  PMID: 38098221 DERIVED

• Gonzalez R, Garcia-Otero L, Pons-Duran C, Marban-Castro E, Gonce A, Llurba E, Gil MDM, Rodriguez-Zambrano MA, Chen H, Ramirez M, Bardaji A, Menendez C. Hydroxychloroquine efficacy and safety in preventing SARS-CoV-2 infection and COVID-19 disease severity during pregnancy (COVID-Preg): a structured summary of a study protocol for a randomised placebo controlled trial. Trials. 2020 Jul 2;21(1):607. doi: 10.1186/s13063-020-04557-y.

  PMID: 32616063 DERIVED

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Interventions

Hydroxychloroquine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, double-blinded, placebo-controlled multicentre clinical trial.

Study Record Dates

• First Submitted: May 26, 2020
• First Posted: June 1, 2020
• Study Start: May 13, 2020
• Primary Completion: June 30, 2021
• Study Completion: October 31, 2021
• Last Updated: January 12, 2022

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: By the end of study

Locations

ES (9)