Pregnancy RelatedPhase 3COVID-PregNCT04410562
Hydroxychloroquine Efficacy and Safety in Preventing SARS-CoV-2 Infection and COVID-19 Disease Severity During Pregnancy and Postpartum
A Phase 3 study testing Hydroxychloroquine in people with Pregnancy Related and COVID, run by Barcelona Institute for Global Health at 9 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related, COVID, Covid-19
- What is being tested?
- Hydroxychloroquine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 129 participants
- Where
- 9 sitesSpain
- Study dates
- 13 May 2020to 31 Oct 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Spain9 sites
Hospital Universitario Fundación Alcorcón
Alcorcón, Madrid, 28922
Hospital del Mar
Barcelona, Catalonia, 08003
Hospital Clínic de Barcelona
Barcelona, Catalonia, 08036
Hospital de la Sant Creu i Sant Pau
Barcelona, Catalonia, 08041
Hospital Sant Joan de Déu
Esplugues de Llobregat, Catalonia, 08950
Hospital Universitario Infanta Leonor
Madrid, 28031
HM Puerta del Sur
Móstoles, Madrid, 28938
Hospital General de Segovia
Segovia, Cartilla Y León, 40002
Hospital Universitario de Torrejón
Torrejón de Ardoz, Madrid, 28850
About this study
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.
Read the 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.
- Conditions
- Pregnancy Related, COVID, Covid-19
- Being tested
- Hydroxychloroquine, Placebo
- Keywords
- pregnancy, covid-19, coronavirus, hydroxychloroquine
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called Dolquine
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).
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 21 days after intervention
Secondary outcomes (20)
Incidence of COVID-19 disease during pregnancy
Measured: through study completion, an average of 1 year
Incidence of COVID-19-related admissions
Measured: through study completion, an average of 1 year
Incidence of all-cause admissions
Measured: through study completion, an average of 1 year
Incidence of all-cause outpatient attendances
Measured: through study completion, an average of 1 year
Mean duration of symptoms-signs of COVID-19
Measured: through study completion, an average of 1 year
Frequency and severity of adverse events
Measured: through study completion, an average of 1 year
Incidence of preeclampsia
Measured: through study completion, an average of 1 year
Incidence of gestational diabetes
Measured: through study completion, an average of 1 year
Incidence of SARS-CoV-2 infections during pregnancy
Measured: through study completion, an average of 1 year
Prevalence of intrauterine growth restriction
Measured: through study completion, an average of 1 year
Maternal mortality rate
Measured: through study completion, an average of 1 year
Proportion of neonates with SARS-CoV-2- intrauterine infection by PCR-confirmed SARS-CoV-2-infection in nasopharyngeal aspirate.
Measured: through study completion, an average of 1 year
Proportion of neonates with clinical signs/symptoms of COVID-19
Measured: through study completion, an average of 1 year
Prevalence of low birth weight (<10th centile according to local standards)
Measured: through study completion, an average of 1 year
Prevalence of preterm birth (<37 weeks of gestational age)
Measured: through study completion, an average of 1 year
Prevalence of embryo and foetal losses (miscarriages and stillbirths)
Measured: through study completion, an average of 1 year
Frequency of congenital malformations
Measured: through study completion, an average of 1 year
Proportion of adverse perinatal outcome
Measured: through study completion, an average of 1 year
Neonatal morbidity
Measured: through study completion, an average of 1 year
Neonatal mortality rate
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2020
- Study start13 May 2020
- Primary completion30 Jun 2021
- Study completion31 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blinded, placebo-controlled multicentre clinical trial.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barcelona Institute for Global Health
- Sponsor type
- University, hospital or other
- 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, Hospital Sant Joan de Deu, Hospital del Mar, Hospital Universitario Infanta Leonor, Hospital Universitario Fundación Alcorcón, Hospital General de Segovia, Institut Català de la Salut
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04410562
- Sponsor's protocol ID
- 2020-001587-29
- Acronym
- COVID-Preg
- Status last verified
- Apr 2021
- First submitted
- 26 May 2020
- Last updated
- 12 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: It would be shared at time of publication.
Publications
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.
PubMed 38098221Gonzalez 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.
PubMed 32616063
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hydroxychloroquine Efficacy and Safety in Preventing SARS-CoV-2 Infection and COVID-19 Disease Severity During Pregnancy and Postpartum
- ClinicalTrials.gov ID
- NCT04410562
- Acronym / sponsor ID
- COVID-Preg / 2020-001587-29
- Conditions
- Pregnancy Related, COVID, Covid-19
- Keywords
- pregnancy, covid-19, coronavirus, hydroxychloroquine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Barcelona Institute for Global HealthUniversity, hospital or other
- 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, Hospital Sant Joan de Deu, Hospital del Mar, Hospital Universitario Infanta Leonor, Hospital Universitario Fundación Alcorcón, Hospital General de Segovia, Institut Català de la Salut
- Study start
- 13 May 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 1 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double-blinded, placebo-controlled multicentre clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Hydroxychloroquine | Experimental | Drug: HydroxychloroquineParticipants 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) |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will be then randomized in a 1:1 ratio to placebo (2 tablets for three days, followed by one tablet for 11 days). |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HydroxychloroquineAlso: DolquineParticipants 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). | Drug | Hydroxychloroquine |
| PlaceboParticipants 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. | Drug | Placebo |
Primary outcome
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
20 secondary outcomes
Incidence of COVID-19 disease during pregnancy
Time frame: through study completion, an average of 1 year
Incidence of COVID-19-related admissions
Time frame: through study completion, an average of 1 year
Incidence of all-cause admissions
Time frame: through study completion, an average of 1 year
Incidence of all-cause outpatient attendances
Time frame: through study completion, an average of 1 year
Mean duration of symptoms-signs of COVID-19
Time frame: through study completion, an average of 1 year
Frequency and severity of adverse events
Time frame: through study completion, an average of 1 year
Incidence of preeclampsia
Time frame: through study completion, an average of 1 year
Incidence of gestational diabetes
Time frame: through study completion, an average of 1 year
Incidence of SARS-CoV-2 infections during pregnancy
Time frame: through study completion, an average of 1 year
Prevalence of intrauterine growth restriction
Time frame: through study completion, an average of 1 year
Maternal mortality rate
Time frame: through study completion, an average of 1 year
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
Proportion of neonates with clinical signs/symptoms of COVID-19
Time frame: through study completion, an average of 1 year
Prevalence of low birth weight (<10th centile according to local standards)
Time frame: through study completion, an average of 1 year
Prevalence of preterm birth (<37 weeks of gestational age)
Time frame: through study completion, an average of 1 year
Prevalence of embryo and foetal losses (miscarriages and stillbirths)
Time frame: through study completion, an average of 1 year
Frequency of congenital malformations
Time frame: through study completion, an average of 1 year
Proportion of adverse perinatal outcome
Time frame: through study completion, an average of 1 year
Neonatal morbidity
Time frame: through study completion, an average of 1 year
Neonatal mortality rate
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2022.
- Derived from this study: PubMed 38098221Gonzalez 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.
- Derived from this study: PubMed 32616063Gonzalez 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.
- Individual participant dataSharing planned: Yes. It would be shared at time of publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hydroxychloroquine in people with Pregnancy Related and COVID, run by Barcelona Institute for Global Health at 9 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of PCR confirmed cases among pregnant women (time frame: 21 days after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04410562, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2022.