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COVIDPhase 3NCT04420247

Efficacy of Chloroquine or Hydroxychloroquine in Treating Pneumonia Caused by SARS-Cov-2 - COVID-19

A Phase 3 study testing Chloroquine and Hydroxychloroquine in people with COVID and COVID-19, run by Centro de Estudos e Pesquisa em Emergencias Medicas e Terapia Intensiva at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Facing the challenge of finding an efficient treatment for COVID-19, the viral pneumonia caused by the Coronavirus SARS-Cov-2, this study intended to test if Chloroquine or Hydroxychloroquine, two drugs with strong in-vitro antiviral role proven by numerous studies and with a well defined safety profile established… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
COVID, COVID-19, SARS-CoV 2
What is being tested?
Chloroquine and Hydroxychloroquine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
142 participants
Where
1 siteBrazil
Study dates
16 Apr 2020to 3 Sep 2020
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult Males and non-pregnant females that accept and sign the informed consent.
  • Hospitalized with COVID-19 suspection that has collected the confirmatory test
  • To have at least one of thes symptoms: Fever, coughing, throat ache or runny nose.
  • To have at least one of these findings: radiological findings that indicates COVID-10 (bilatareal ground grass images); O2 saturation lower than 94% without supplementation and crackles in lung auscultation; Need of O2 supplementation; Need of Mechanical Ventilation.
  • Female patients must also agree to use efficient counterceptive methods during the evaluation period.

Who cannot join

  • Patients with psoriasis or other exfoliative disease, porphyria, epilepsy, myasthenia gravis, advanced liver failure or glucose-6-phosphate dehydrogenase deficiency.
  • ALT / AST> 5 times the upper limit of normal.
  • Severe chronic kidney disease in stage 4 or requiring dialysis (ie, eGFR <30).
  • Pregnancy or breastfeeding.
  • Early transfer to another hospital that is not a study site within 72 hours.
  • Severe heart disease and / or a history of cardiac arrhythmia.
  • Allergy to Chloroquine and / or Hydroxychloroquine.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Centro de Estudos e Pesquisa em Emergencias Clinicas e Terapia Intensiva

    Curitiba, Paraná, 82530200

Other trials in Brazil

About this study

Official title: Multicentric Pragmatic Randomized Controled Trial to Evaluate the Efficacy Chloroquine or Hydroxychloroquine for Five Days in Treating Pneumonia Caused by SARS-Cov-2 - COVID-19

Facing the challenge of finding an efficient treatment for COVID-19, the viral pneumonia caused by the Coronavirus SARS-Cov-2, this study intended to test if Chloroquine or Hydroxychloroquine, two drugs with strong in-vitro antiviral role proven by numerous studies and with a well defined safety profile established, for efficacy in treating COVID-19 and improving an ordinal primary outcome composed by a 9-levels scale, which was recomended by the World Health Organization.

Read the detailed description

This is a Phase 3, Pragmatic, Multicentric Randomized Controled Trial of efficacy to test the effect of either Chloroquine or Hydroxychloroquine for 5 days in the recomended dose standardized by brazilian Ministry of Health.

Patients were randomized (1:1) using stratified randomization by hospital and severity at the moment of randomization (stipulated by use of mechanical ventilation or not) into two arms: Intervention and Control. Intervention group recieved a loading dose of 900mg of Chloroquine or 800mg of Hydroxycloroquine in the first day, followed by 450mg of chloroquine of 400mg of hydroxychloroquine. Primary and secondary outcomes were evaluated on the 5th, 7th, 10th, 14th, 28th day after randomization.

Although the outcomes presented in the latest version were updated late on ClinicalTrials.org, on October 23, 2020, these outcomes were already present in the trial protocol approved by the Brazilian National Commission for Ethics in Research on April 8, 2020 (approval number: 3960331) and amending the protocol, approved by the same National Commission on May 25, 2020 (approval number: 4044848)

Being tested
Chloroquine, Hydroxychloroquine, standard care
Keywords
VIRAL PNEUMONIA, CORONAVIRUS, COVID-19, COVID, SARS-COV-2
Medical subject headings
COVID-19, Coronavirus Infections, Pneumonia, Viral

What participants receive

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

  • ChloroquineDrug

    5 days of treatment with Chloroquine + Standard Care

  • HydroxychloroquineDrug

    5 days of treatment with Hydroxychloroquine + Standard Care

  • standard careOther

    Standard Care according to Brazilian Guidelines for treating COVID-19

Study groups in NCT04420247
Study groupRoleWhat they receive
InterventionExperimentalTreatment with either Chloroquine or Hydroxychloroquine according to what was available in the hospital: Chloroquine - 900mg on the first day, followed by 450mg in the next 4 days. Hydroxychloroquine - 800mg on the first day, followed by 450mg in the next 4 days. + Standard treatment available and recomended by the Brazilian Guidelines for COVID-19.
Receives: Drug: Chloroquine; Drug: Hydroxychloroquine
ControlActive comparatorStandard treatment available and recomended by the Brazilian Guidelines for COVID-19.
Receives: Other: standard care

What is being measured

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

  1. World Health Organization (WHO) 9-levels ordinal scale (from 0-8)

    Evaluation of the clinical status of patients on the 14th day after randomization defined by the 9-levels ordinal scale, with lower scores meaning better outcomes.

    Measured: 14 days after randomization

Secondary outcomes (11)

  1. World Health Organization (WHO) 9-levels ordinal scale (from 0-8)

    Evaluation of the clinical status of patients on the 5th, 7th, 10th and 28th day after randomization defined by the 9-levels ordinal scale, with lower scores meaning better outcomes.

    Measured: 5, 7, 10 and 28 days after randomization

  2. Mortality

    All-cause mortality at 28 days after randomization

    Measured: 28 days after randomization

  3. Ventilation free days

    Number of days without need of Mechanical Ventilation at 28 days after randomization

    Measured: 28 days after randomization

  4. ICU Lenght of Stay

    ICU Lenght of Stay on survivors at 28 days after randomization

    Measured: 28 days after randomization

  5. Hospital Lenght of Stay

    Hospital Lenght of Stay on survivors at 28 days after randomization

    Measured: 28 days after randomization

  6. Acute Kidney Disease incidence

    Acute Kidney Disease incidence measured by Kidney Disease Improving Global Outcomes (KDIGO) stage 3 sometime until the 28th day after randomization.

    Measured: 28 days after randomization

  7. Percentage of patients needing dialysis

    Percentage of patients needing dialysis sometime until the 28th day.

    Measured: 28 days after randomization

  8. Coagulopathy incidence

    Presence of coagulopathy sometime until the 28th day (platelets < 150000 and/or INR >1.5 and/or KPTT > 35 seconds).

    Measured: 28 days after randomization

  9. Mean of C Reactive Protein Levels

    Mean of C Reactive Protein Levels on the 5th, 7th, 10th, 14th and 28th day after randomization, during period of hospitalization

    Measured: 5, 7, 10, 14 and 28 days after randomization

  10. Sequential Organ Failure Assessment (SOFA) scores

    Sequential Organ Failure Assessment (SOFA) scores (range, 0-24, with higher scores indicating greater organ dysfunction) on the 5th, 7th, 10th, 14th and 28th day after randomization, during period of hospitalization.

    Measured: 5, 7, 10, 14 and 28 days after randomization

  11. Neutrophils/lymphocytes ratio

    Neutrophils/lymphocytes ratio on the 5th, 7th, 10th, 14th and 28th day after randomization, during period of hospitalization.

    Measured: 5, 7, 10, 14 and 28 days after randomization

Timeline

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

  1. First posted9 Jun 2020
  2. Study start16 Apr 2020
  3. Primary completion20 Aug 2020
  4. Study completion3 Sep 2020

Resources

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
Two arms - Intervention and Control Intervention received unblinded treatment with Chloroquine or Hyroxycloroquine for 5 days, as well as standard treatment available and recomended by the Brazilian Guidelines for COVID-19. Control group received just the standard treatment available and recomended by the Brazilian Guidelines for COVID-19.
Masking
None (open label)
Enrolment
142 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04420247
Sponsor's protocol ID
CLOROTRIAL
Status last verified
May 2021
First submitted
2 Jun 2020
Last updated
12 May 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Rea-Neto A, Bernardelli RS, Camara BMD, Reese FB, Queiroga MVO, Oliveira MC. An open-label randomized controlled trial evaluating the efficacy of chloroquine/hydroxychloroquine in severe COVID-19 patients. Sci Rep. 2021 Apr 27;11(1):9023. doi: 10.1038/s41598-021-88509-9.

    PubMed 33907251

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Chloroquine and Hydroxychloroquine in people with COVID and COVID-19, run by Centro de Estudos e Pesquisa em Emergencias Medicas e Terapia Intensiva at 1 site in Brazil.

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 5 inclusion and 7 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 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. 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. 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?

World Health Organization (WHO) 9-levels ordinal scale (from 0-8) (time frame: 14 days after randomization). 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 NCT04420247, which also lists 1 linked publication.

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 May 2021.

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