COVID 19Phase 4NCT04330495

Randomized, Controlled, Double-blind Clinical Trial Comparing the Efficacy and Safety of Chemoprophylaxis With Hydroxychloroquine in Patients Under Biological Treatment and / or JAK Inhibitors in the Prevention of SARS-CoV-2 Infection

A Phase 4 study testing Hidroxicloroquina in people with COVID 19 and Immunomediated Inflammatory Disease in Treatment With Biological Agents and / or Jak Inhibitors, run by Instituto de Investigación Marqués de Valdecilla.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: COVID 19, Immunomediated Inflammatory Disease in Treatment With Biological Agents and / or Jak Inhibitors
What is being tested?: Hidroxicloroquina
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: No sites listed yet
Study dates: 6 Apr 2020to 27 Aug 2021
Phase: Phase 4
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 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients who meet the requirements of the New Coronavirus Infection Diagnosis (Acute respiratory infection symptoms or acute cough alone and positive PCR)
Aged ≥18 and < 75 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,
Diagnosis of IBD disease, rheumatoid arthritis, seronegative spondyloarthritis or psoriasis for more than 6 months.
Be on stable treatment with biological agents, for a minimum period of 6 months, including treatment with Infliximab, etanercept, adalimumab, certolizumab, golimumab, rituximab, abatacept, tocilizumab, sarilumab, secukinumab, vedolizumab, natalizumab, ustekinumab, tofacit
Able to provide oral and written informed consent

Who cannot join

Previous infection with SARS-CoV-2.
Current treatment with hydroxychloroquine / chloroquine.
Previous or current treatment with tamoxifen or raloxifene.
Previous eye disease, especially maculopathy.
Known heart failure grade III-IV of the classification of the New York Heart Association).
Any type of cancer (except basal cell) in the last 5 years.

Show all 15Show fewer

Pregnancy.
Refusal to give informed consent.
Evidence of any other unstable or clinically significant unstable, clinically significant, immunological, endocrine, hematologic, gastrointestinal, neurological, neoplastic, or psychiatric illness.
Instability or mental incompetence, so that the validity of the informed consent or the ability to complete the study is uncertain.
Positive antibodies to the human immunodeficiency virus.
Data on decompensated liver disease:
to. Aspartate aminotransferase (AST) and / or ALT> 10 x upper limit of normal (LSN).
Total bilirubin> 25 μmol / l (1.5 mg / dl). c. International normalized index> 1.4. d. Platelet count <100,000 / mm3. 17. Serum creatinine levels> 135 μmol / l (> 1.53 mg / dl) in men and> 110 μmol / l (> 24 mg / dl) in women.
18.Significant kidney disease, including nephrotic syndrome, chronic kidney disease (patients with markers of liver injury or estimated glomerular filtration rate [eGFR] of less than 60 ml / min / 1.73 m2). If an abnormal value is obtained at the first screening visit, the measurement of eGFR may be repeated before randomization within the following time frame: minimum 4 weeks after the initial test and maximum 2 weeks before the planned randomization. Repeated abnormal eGFR (less than 60 ml / min / 1.73 m2) leads to exclusion from the study.Pregnant or lactating women; 19. Inability to consent and/or comply with study protocol; 20. Individuals with known hypersensitivity to the study drugs. 21. Any contraindications as per the Data Sheet of or Hydroxychloroquine.

About this study

The investigators plan to evaluate a strategy of chemoprophylaxis with hydroxyloquine (HCQ) against COVID-19 infection in patients diagnosed with an immunomediated inflammatory disease who are following a treatment with biological agents and / or Jak inhibitors. The strategy will be carried out through a randomised double blind, placebo-controlled clinical trial and will assess comparative rates of infection (prevalence, incidence), severity including mortality, impact on clínical course of the primary diseases and toxicity. Such evaluation will require prospective surveillance to assess the different end-points.

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

Conditions: COVID 19, Immunomediated Inflammatory Disease in Treatment With Biological Agents and / or Jak Inhibitors
Being tested: Hidroxicloroquina, Control group
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HidroxicloroquinaDrug
Chemoprophylaxis with hydroxychloroquine at a dose of 200 mg twice a day for 6 months.
Control groupDrug
Testing of SARS-CoV-2 and prescription of placebo (Hydroxychloroquine placebo) twice daily for 6 months

Study groups in NCT04330495
Study group	Role	What they receive
Testing and prophylaxis of SARS-CoV-2	Experimental	Chemoprophylaxis with hydroxychloroquine at a dose of 200 mg twice a day for 6 months. Receives: Drug: Hidroxicloroquina
placebo	Active comparator	Testing of SARS-CoV-2 and prescription of placebo (Hydroxychloroquine placebo) twice daily for 6 months Receives: Drug: Control group

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence rate of new COVID-19 cases in both arms
number of new cases divided by number of persons-time at risk
Measured: From day 14 after start of treatment up to the end of follow-up: week 27
Prevalence of COVID-19 cases in both arms
percentage of cases of COVID 19
Measured: 27 weeks after the beginning of the study
Mortality rate secondary to COVID-19 cases in both groups
Case fatality rate (CFR): the proportion of diagnosed cases of COVID 19 that lead to death
Measured: 27 weeks after the beginning of the study
Intensive Care Unit (CU) admission rate secondary to COVID-19 cases in both groups
percentage of patients who need admission in an ICU due to COVID 19 infection
Measured: 27 weeks after the beginning of the study

Secondary outcomes (2)

Adverse events
Presence and type of adverse events at this point.
Measured: 12 weeks after the start of treatment
Adverse events
Proportion of participants that drop out of study
Measured: 27 weeks after the beginning of the study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Apr 202027 Aug 2021

First posted1 Apr 2020
Study start6 Apr 2020 (estimated)
Primary completion6 Nov 2020 (estimated)
Study completion27 Aug 2021

Why it stopped: * Care pressures on the investigator team during the COVID-19 pandemic. * Subsequent appearance of scientific evidence on the lack of efficacy of hydroxychloroquine in the treatment or prophylaxis of COVID-19 infection.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for COVID 19Studies 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 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: Randomized, controlled, double-blind clinical trial
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04330495
Sponsor's protocol ID: EnCOVID-HidroxiCLOROQUINA
Status last verified: Sep 2021
First submitted: 31 Mar 2020
Last updated: 16 Sep 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingPhase 4
Comparative Immunogenicity of Respiratory Virus Vaccines (CIRV2) Study
COVID -19, COVID - 19
Not yet recruitingPhase 2
Study of VYD2311 for the Treatment of Adults With Long-COVID or Post-Vaccination Syndrome
Long COVID, COVID-19 (SARS-CoV-2 Infection)
RecruitingPhase 2
COVID-19 Booster and IIV Schedule in Immunocompromised Hosts
COVID 19, Influenza
RecruitingObservational study
Natural History of Post-Coronavirus Disease 19 Convalescence at the National Institutes of Health
Post-Coronavirus Disease 19
Not yet recruitingPhase 1/2
Taurine Supplementation in Adolescents With Post-COVID Condition
Long COVID, Post COVID-19 Condition

All COVID 19 trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized, Controlled, Double-blind Clinical Trial Comparing the Efficacy and Safety of Chemoprophylaxis With Hydroxychloroquine in Patients Under Biological Treatment and / or JAK Inhibitors in the Prevention of SARS-CoV-2 Infection
ClinicalTrials.gov ID: NCT04330495
Acronym / sponsor ID: EnCOVID-HidroxiCLOROQUINA
Conditions: COVID 19, Immunomediated Inflammatory Disease in Treatment With Biological Agents and / or Jak Inhibitors
Phase: Phase 4
Study type: Interventional
Recruitment status: WithdrawnReason stopped: * Care pressures on the investigator team during the COVID-19 pandemic. * Subsequent appearance of scientific evidence on the lack of efficacy of hydroxychloroquine in the treatment or prophylaxis of COVID-19 infection.
Enrolment: 0 participants (actual)
Lead sponsor: Instituto de Investigación Marqués de ValdecillaUniversity, hospital or other
Study start: 6 Apr 2020 (estimated)
Primary completion: 6 Nov 2020 (estimated)
Study completion: 27 Aug 2021 (actual)
First posted: 1 Apr 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.

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

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2
Model description: Randomized, controlled, double-blind clinical trial

Arm	Type	Receives
Testing and prophylaxis of SARS-CoV-2	Experimental	Drug: HidroxicloroquinaChemoprophylaxis with hydroxychloroquine at a dose of 200 mg twice a day for 6 months.
placebo	Active comparator	Drug: Control groupTesting of SARS-CoV-2 and prescription of placebo (Hydroxychloroquine placebo) twice daily for 6 months

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Patients who meet the requirements of the New Coronavirus Infection Diagnosis (Acute respiratory infection symptoms or acute cough alone and positive PCR)
Aged ≥18 and < 75 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,

Key exclusion criteria (15 listed)

Previous infection with SARS-CoV-2.
Current treatment with hydroxychloroquine / chloroquine.
Previous or current treatment with tamoxifen or raloxifene.
Previous eye disease, especially maculopathy.
Known heart failure grade III-IV of the classification of the New York Heart Association).

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
HidroxicloroquinaChemoprophylaxis with hydroxychloroquine at a dose of 200 mg twice a day for 6 months.	Drug	Testing and prophylaxis of SARS-CoV-2
Control groupTesting of SARS-CoV-2 and prescription of placebo (Hydroxychloroquine placebo) twice daily for 6 months	Drug	placebo

Primary outcome

Incidence rate of new COVID-19 cases in both arms
Time frame: From day 14 after start of treatment up to the end of follow-up: week 27
number of new cases divided by number of persons-time at risk
Prevalence of COVID-19 cases in both arms
Time frame: 27 weeks after the beginning of the study
percentage of cases of COVID 19
Mortality rate secondary to COVID-19 cases in both groups
Time frame: 27 weeks after the beginning of the study
Case fatality rate (CFR): the proportion of diagnosed cases of COVID 19 that lead to death
Intensive Care Unit (CU) admission rate secondary to COVID-19 cases in both groups
Time frame: 27 weeks after the beginning of the study
percentage of patients who need admission in an ICU due to COVID 19 infection

2 secondary outcomes

Adverse events
Time frame: 12 weeks after the start of treatment
Adverse events
Time frame: 27 weeks after the beginning of the study

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
Individual participant dataSharing planned: Undecided

Related trials for COVID 19

RecruitingPhase 4
Comparative Immunogenicity of Respiratory Virus Vaccines (CIRV2) Study
COVID -19, COVID - 19
Not yet recruitingPhase 2
Study of VYD2311 for the Treatment of Adults With Long-COVID or Post-Vaccination Syndrome
Long COVID, COVID-19 (SARS-CoV-2 Infection)
RecruitingPhase 2
COVID-19 Booster and IIV Schedule in Immunocompromised Hosts
COVID 19, Influenza
RecruitingObservational study
Natural History of Post-Coronavirus Disease 19 Convalescence at the National Institutes of Health
Post-Coronavirus Disease 19
Not yet recruitingPhase 1/2
Taurine Supplementation in Adolescents With Post-COVID Condition
Long COVID, Post COVID-19 Condition

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.

Questions about this trial

What is this clinical trial studying?

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 8 inclusion and 15 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: withdrawn, as of the sponsor's last update on 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 was withdrawn before enrolling participants, so there are no results.

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?

Incidence rate of new COVID-19 cases in both arms (time frame: From day 14 after start of treatment up to the end of follow-up: week 27). The study lists 4 primary outcomes in all. 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 NCT04330495.

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 16 Sep 2021; AzTrials last refreshed its copy on 30 Oct 2026.