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

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ClinicalTrials.gov Identifier: NCT04410562
Recruitment Status : Recruiting
First Posted : June 1, 2020
Last Update Posted : June 1, 2020
Sponsor:
Collaborators:
Hospital Clinic of Barcelona
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
University Hospital of Torrejon
Fundación de investigación HM
Information provided by (Responsible Party):
Barcelona Institute for Global Health

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.

Condition or disease Intervention/treatment Phase
Pregnancy Related COVID Covid-19 Drug: Hydroxychloroquine Drug: Placebo Phase 3

Detailed Description:
This is a randomized, double blinded, placebo-controlled multicenter clinical trial including 714 pregnant women (200 SARS-CoV-2 infected -100 symptomatic with mild disease and 100 asymptomatic- pregnant women and 514 SARS-CoV-2 uninfected pregnant women who are contacts with a SARS-CoV-2 case) with the main objectives of assessing the safety and efficacy of oral hydroxychloroquine (HCQ) in reducing maternal viral shedding by PCR, and preventing incident SARS-CoV-2 infection and disease severity. Pregnant women undergoing antenatal follow up at five maternity hospitals, presenting at least one sign and/or one mild suggestive symptoms and a positive SARS-CoV-2 PCR test, or who are contacts of a suspected or confirmed case, will be recruited and randomized 1:1 to receive HCQ orally (400 mg/day for 3 days, followed by 200 mg/day for 11 days) or placebo. Women will be followed up for the duration of the intervention. One week after intervention completion, a SARS-CoV-2 PCR test will be repeated. At delivery, the pregnancy outcome will be registered, and a cord blood sample will be collected to measure for IgG and IgM of SARS-CoV-2. A neonatal nasopharyngeal aspirate will be collected to perform PCR SARS-CoV-2 testing.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 714 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, double-blinded, placebo-controlled multicentre clinical trial.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Hydroxychloroquine Efficacy and Safety in Preventing SARS-CoV-2 Infection and COVID-19 Disease Severity During Pregnancy
Actual Study Start Date : May 13, 2020
Estimated Primary Completion Date : May 13, 2021
Estimated Study Completion Date : August 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Hydroxychloroquine
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
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).
Other Name: Dolquine

Placebo Comparator: Placebo
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
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.




Primary Outcome Measures :
  1. Number of PCR confirmed cases among pregnant women [ Time Frame: 21 days after intervention ]
    Number of PCR-confirmed infected pregnant women assessed from collected nasopharyngeal and oropharyngeal swabs at day 21 after treatment start


Secondary Outcome Measures :
  1. Incidence of COVID-19 disease during pregnancy [ Time Frame: through study completion, an average of 1 year ]
  2. Incidence of COVID-19-related admissions [ Time Frame: through study completion, an average of 1 year ]
  3. Incidence of all-cause admissions [ Time Frame: through study completion, an average of 1 year ]
  4. Incidence of all-cause outpatient attendances [ Time Frame: through study completion, an average of 1 year ]
  5. Mean duration of symptoms-signs of COVID-19 [ Time Frame: through study completion, an average of 1 year ]
  6. Frequency and severity of adverse events [ Time Frame: through study completion, an average of 1 year ]
  7. Incidence of preeclampsia [ Time Frame: through study completion, an average of 1 year ]
  8. Incidence of gestational diabetes [ Time Frame: through study completion, an average of 1 year ]
  9. Incidence of SARS-CoV-2 infections during pregnancy [ Time Frame: through study completion, an average of 1 year ]
  10. Prevalence of intrauterine growth restriction [ Time Frame: through study completion, an average of 1 year ]
  11. Maternal mortality rate [ Time Frame: through study completion, an average of 1 year ]
  12. Proportion of neonates with SARS-CoV-2- intrauterine infection by PCR-confirmed SARS-CoV-2-infection in nasopharyngeal aspirate. [ Time Frame: through study completion, an average of 1 year ]
  13. Proportion of neonates with clinical signs/symptoms of COVID-19 [ Time Frame: through study completion, an average of 1 year ]
  14. Prevalence of low birth weight (<10th centile according to local standards) [ Time Frame: through study completion, an average of 1 year ]
  15. Prevalence of preterm birth (<37 weeks of gestational age) [ Time Frame: through study completion, an average of 1 year ]
  16. Prevalence of embryo and foetal losses (miscarriages and stillbirths) [ Time Frame: through study completion, an average of 1 year ]
  17. Frequency of congenital malformations [ Time Frame: through study completion, an average of 1 year ]
  18. Proportion of adverse perinatal outcome [ Time Frame: through study completion, an average of 1 year ]
  19. Neonatal morbidity [ Time Frame: through study completion, an average of 1 year ]
  20. Neonatal mortality rate [ Time Frame: through study completion, an average of 1 year ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04410562


Contacts
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Contact: Clara Menéndez, MD.PhD +34 932275400 ext 3166 clara.menendez@isglobal.org
Contact: Raquel González, MD.PhD +34 932275400 ext 4144 raquel.gonzalez@isglobal.org

Locations
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Spain
Hospital Sant Creu i Sant Pau Recruiting
Barcelona, Catalunya, Spain, 08001
Contact: Elisa Llurba, MD PhD    93 291 90 00    Elisa.Llurba@uab.cat   
Hospital Clínic Maternity Recruiting
Barcelona, Catalunya, Spain, 08028
Contact: Anna Gonce, MD PhD    +34 93 227 5400    AGONCE@clinic.cat   
University hospital of Torrejón Recruiting
Madrid, Spain, 28850
Contact: Maria dh Mar Mar Gil, Md PhD    916 26 26 26    mgil@torrejonsalud.com   
HM Puerta del Sur Recruiting
Madrid, Spain, 28938
Contact: Miguel Ángeles, MD    902 08 98 00    mrodzambrano@gmail.com   
Sponsors and Collaborators
Barcelona Institute for Global Health
Hospital Clinic of Barcelona
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
University Hospital of Torrejon
Fundación de investigación HM
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Barcelona Institute for Global Health
ClinicalTrials.gov Identifier: NCT04410562    
Other Study ID Numbers: 2020-001587-29
First Posted: June 1, 2020    Key Record Dates
Last Update Posted: June 1, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: It would be shared at time of publication.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: By the end of study

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Barcelona Institute for Global Health:
pregnancy
covid-19
coronavirus
hydroxychloroquine
Additional relevant MeSH terms:
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Infection
Hydroxychloroquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents