COVID-19Phase 2CloroCOVID19IINCT04342650
Chloroquine Diphosphate in the Prevention of SARS in Covid-19 Infection
A Phase 2 study testing Chloroquine Diphosphate in people with COVID-19 and SARS-CoV Infection, run by Fundação de Medicina Tropical Dr. Heitor Vieira Dourado at 1 site in Brazil.
Trial summary
This is a double-blind, randomized, placebo-controlled clinical trial. A total of 210 individuals aged over 18 years old, without a diagnosis of severe respiratory disease, who came to the study site with clinical and radiological suspicion of SARS-CoV2, will be randomized into two treatment groups at a 1:1 ratio to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, SARS-CoV Infection, Severe Acute Respiratory Syndrome (SARS) Pneumonia
- What is being tested?
- Chloroquine Diphosphate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 152 participants
- Where
- 1 siteBrazil
- Study dates
- 8 Apr 2020to 8 Jun 2020
- Phase
- Phase 2
- 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
- Suspected cases of COVID-19, due to clinical and radiological data, during the epidemic;
- Adult aged 18 or over, at the time of inclusion
- Not having severe acute respiratory syndrome (SARS), that is, not using mechanical ventilation or supplemental oxygen, peripheral oxygen saturation> 94% in room air, and having a respiratory rate below 24 incursions per minute.
- Patients with comorbidities only, due to the increased risk of developing SARS
Who cannot join
- 1. Patients with chronic use of drugs known to prolong QTc interval.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital e Pronto Socorro Delphina Rinaldi Abdel Aziz
Manaus, Amazonas, 69093-415
About this study
Official title: Phase IIb Study to Evaluate the Efficacy and Safety of Chloroquine Diphosphate in the Treatment of Patients With Comorbidities, Without Severe Acute Respiratory Syndrome, Under the New Coronavirus (SARS-CoV2): a Double-blind, Randomized, Placebo-controlled Clinical Trial
This is a double-blind, randomized, placebo-controlled clinical trial. A total of 210 individuals aged over 18 years old, without a diagnosis of severe respiratory disease, who came to the study site with clinical and radiological suspicion of SARS-CoV2, will be randomized into two treatment groups at a 1:1 ratio to receive a 5-day CQ diphosphate tablets or placebo (tablet without active ingredient produced with the same physical characteristics).
- Conditions
- COVID-19, SARS-CoV Infection, Severe Acute Respiratory Syndrome (SARS) Pneumonia, Clinical Trial
- Being tested
- Chloroquine Diphosphate, Placebo oral tablet
- Medical subject headings
- COVID-19, Severe Acute Respiratory Syndrome, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chloroquine DiphosphateDrug
Also called chloroquine
150mg tablets Note: Tablets used in the study were Chloroquine Diphosphate (produced by Farmanguinhos/Fiocruz), and the dosing stated in the clinicaltrials.gov refers to chloroquine base (in mg).
Placebo oral tabletDrug
150mg placebo tablets
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | CQ 450mg twice daily (3 tablets of 150mg, every 12 hours) on day 1, followed by CQ 450mg once daily (3 tablets of 150mg) from D2 to D5. Oral administration. Receives: Drug: Chloroquine Diphosphate |
| Placebo | Placebo comparator | Placebo tables of equal characteristics and duration of treatment. Receives: Drug: Placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with onset of severe acute respiratory syndrome (SARS)
Evaluate if CQ diphosphate prevents the onset of SARS in patients on intervention group through standardized questionnaires.
Measured: 7 days after randomization
Secondary outcomes (9)
Mortality rate
Mortality rate between intervention and placebo group on days 7, 14, and 28 after randomization
Measured: after randomization, up to 28 days
Number of participants in need of intensive care support
Proportion of participants in need and duration of intensive care support after randomization
Measured: during and after intervention, up to 28 days
Viral concentration
Viral load change in blood and oropharyngeal swab samples
Measured: After randomization, up to 7 days
Cumulative incidence of serious adverse events
Incidence of serious adverse events during and after treatment
Measured: During and after intervention, up to 28 days
Cumulative incidence of grade 3 and 4 adverse events
Incidence of grade 3 and 4 adverse events during and after treatment
Measured: During and after intervention, up to 28 days
Proportion of patients with discontinued treatment
proportion of discontinuation or temporary suspension of treatment (for any reason)
Measured: after randomization, up to 28 days
Incidence of cardiac lesions
proportion of patients with increased levels of troponin I
Measured: after randomization, up to 120 days
Incidence of cardiac disfunctions
proportion and magnitude of QTcF interval increases higher than 500ms
Measured: after randomization, up to 120 days
Change in respiratory capacity
Changes measured on day 120 will be compared to baseline, through spirometry.
Measured: Day 120 after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2020
- Study start8 Apr 2020
- Primary completion14 May 2020
- Study completion8 Jun 2020
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04342650
- Sponsor's protocol ID
- CAAE: 30504220.5.0000.0005
- Acronym
- CloroCOVID19II
- Status last verified
- Jul 2020
- First submitted
- 4 Apr 2020
- Last updated
- 9 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all patient data will be shared after study publication
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IIb Study to Evaluate the Efficacy and Safety of Chloroquine Diphosphate in the Treatment of Patients With Comorbidities, Without Severe Acute Respiratory Syndrome, Under the New Coronavirus (SARS-CoV2): a Double-blind, Randomized, Placebo-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04342650
- Acronym / sponsor ID
- CloroCOVID19II / CAAE: 30504220.5.0000.0005
- Conditions
- COVID-19, SARS-CoV Infection, Severe Acute Respiratory Syndrome (SARS) Pneumonia, Clinical Trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Fundação de Medicina Tropical Dr. Heitor Vieira DouradoUniversity, hospital or other
- Study start
- 8 Apr 2020 (actual)
- Primary completion
- 14 May 2020 (actual)
- Study completion
- 8 Jun 2020 (actual)
- First posted
- 13 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.
This is a double-blind, randomized, placebo-controlled clinical trial. A total of 210 individuals aged over 18 years old, without a diagnosis of severe respiratory disease, who came to the study site with clinical and radiological suspicion of SARS-CoV2, will be randomized into two treatment groups at a 1:1 ratio to receive a 5-day CQ diphosphate tablets or placebo (tablet without active ingredient produced with the same physical characteristics).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Drug: Chloroquine DiphosphateCQ 450mg twice daily (3 tablets of 150mg, every 12 hours) on day 1, followed by CQ 450mg once daily (3 tablets of 150mg) from D2 to D5. Oral administration. |
| Placebo | Placebo comparator | Drug: Placebo oral tabletPlacebo tables of equal characteristics and duration of treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Suspected cases of COVID-19, due to clinical and radiological data, during the epidemic;
- Adult aged 18 or over, at the time of inclusion
- Not having severe acute respiratory syndrome (SARS), that is, not using mechanical ventilation or supplemental oxygen, peripheral oxygen saturation> 94% in room air, and having a respiratory rate below 24 incursions per minute.
- Patients with comorbidities only, due to the increased risk of developing SARS
Key exclusion criteria (1 listed)
- 1. Patients with chronic use of drugs known to prolong QTc interval.
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 |
|---|---|---|
| Chloroquine DiphosphateAlso: chloroquine150mg tablets Note: Tablets used in the study were Chloroquine Diphosphate (produced by Farmanguinhos/Fiocruz), and the dosing stated in the clinicaltrials.gov refers to chloroquine base (in mg). | Drug | Intervention |
| Placebo oral tablet150mg placebo tablets | Drug | Placebo |
Primary outcome
Proportion of patients with onset of severe acute respiratory syndrome (SARS)
Time frame: 7 days after randomization
Evaluate if CQ diphosphate prevents the onset of SARS in patients on intervention group through standardized questionnaires.
9 secondary outcomes
Mortality rate
Time frame: after randomization, up to 28 days
Number of participants in need of intensive care support
Time frame: during and after intervention, up to 28 days
Viral concentration
Time frame: After randomization, up to 7 days
Cumulative incidence of serious adverse events
Time frame: During and after intervention, up to 28 days
Cumulative incidence of grade 3 and 4 adverse events
Time frame: During and after intervention, up to 28 days
Proportion of patients with discontinued treatment
Time frame: after randomization, up to 28 days
Incidence of cardiac lesions
Time frame: after randomization, up to 120 days
Incidence of cardiac disfunctions
Time frame: after randomization, up to 120 days
Change in respiratory capacity
Time frame: Day 120 after randomization
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 9 Aug 2021.
- Individual participant dataSharing planned: Yes. all patient data will be shared after study 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Chloroquine Diphosphate in people with COVID-19 and SARS-CoV Infection, run by Fundação de Medicina Tropical Dr. Heitor Vieira Dourado 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 4 inclusion and 1 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 9 Aug 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Proportion of patients with onset of severe acute respiratory syndrome (SARS) (time frame: 7 days after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Aug 2021.