COVID-19 PneumoniaPhase 2NCT04428268
Chloroquine + Losartan Compared to Chloroquine Alone for the Treatment of COVID-19 Pneumonia
A Phase 2 study testing Chloroquine Phosphate Tablets in people with COVID-19 Pneumonia, run by Hospital Universitario Dr. Jose E. Gonzalez at 1 site in Mexico.
Trial summary
Study design Phase 2, double blinded, single-center, 1:1 randomized clinical trial of Chloroquine vs Chloroquine/losartan for the treatment of SARS-CoV-2 pneumonia in non-critically ill subjects Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Pneumonia
- What is being tested?
- Chloroquine Phosphate Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteMexico
- Study dates
- 10 Mar 2020to 16 Feb 2021
- 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
- Men or women ≥18 years.
- Oral tolerance or access for enteral administration of medication.
- PCR or IgM for SARS-CoV-2 positive.
- Negative pregnancy test in case of a woman of reproductive age.
- Signature of a document proving informed consent.
- Hospital admission for SARS-CoV-2 pneumonia.
Who cannot join
- New alteration of the state of alert that does not revert after interventions 60 minutes after hospital admission.
- Mean Arterial Pressure (MAP) ≤ 65mmHg despite initial resuscitation on arrival at the centre.
- History of allergy to chloroquine, hydroxychloroquine, piperaquine or primaquine.
- Known patient with hearing loss.
- Received chloroquine or hydroxychloroquine in the last 3 months.
- Patients with cirrhosis or elevation of aspartate transaminase (AST) or alanine transaminase (ALT) greater than three times the upper normal limit.
Show all 17Show fewer
- Patients with calculated glomerular filtration rate by Modification of Diet in Renal Disease study equation (MDRD) < 30ml/min 1.73 m2.
- Patients known to be deficient in 6-phosphate dehydrogenase
- Patients known to have retinopathy or macular disease.
- History of acute myocardial infarction in the last 6 months, unstable angina, ventricular tachycardia, ventricular fibrillation or class III-IV heart failure according to New York Heart Association.
- Electrocardiogram QTc interval ≥ 480 ms.
- Patients with hypomagnesemia or uncorrected hypokalemia.
- Patients with a history of psychiatric illness.
- Patients who are pregnant or nursing.
- Patients taking quinolones, dextropropoxyphene, amiodarone, flecainide, cisapride, domperidone, atazanavir or lopinavir.
- Patients with acute pancreatitis.
- Patients who the investigators deem unsuitable for participation in the clinical trial.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital Universitario José E. Gonzalez
Monterrey, Nuevo León, 64460
About this study
Official title: Phase II, Randomized, Double-blind, Controlled Clinical Trial Evaluating the Efficacy and Safety of Chloroquine + Low Dose Losartan Compared to Chloroquine Monotherapy in Subjects With SARS-CoV-2 Pneumonia
Study design Phase 2, double blinded, single-center, 1:1 randomized clinical trial of Chloroquine vs Chloroquine/losartan for the treatment of SARS-CoV-2 pneumonia in non-critically ill subjects
Read the detailed description
Study design Phase 2, blinded, single-center, 1: 1 randomized clinical trial for the treatment of SARS-CoV-2 pneumonia in non-critically ill subjects. Two of the co-investigators and the data analyst will remain blind to group allocation until after statistical analysis.
The groups will consist of subjects receiving in one arm PO Chloroquine 450mg every 12 hours and in the other arm, in addition to chloroquine, PO Losartan 25mg every 24 hours. Study drugs will be administered for a total of 10 days enterally.
Baseline demographics and clinical characteristics will be registered and periodically during the study.
nasopharyngeal swabs will be taken every 48hrs during hospitalization to determine the presences and viral load of SARS-CoV-2, and daily EKG for QT interval monitoring.
- Conditions
- COVID-19 Pneumonia
- Being tested
- Chloroquine Phosphate Tablets
- Keywords
- COVID-19, SARS-CoV-2 pneumonia, Chloroquine phosphate, Losartan
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chloroquine Phosphate TabletsDrug
Also called Losartan tablets
Orally administered
| Study group | Role | What they receive |
|---|---|---|
| Chloroquine | Active comparator | Patients will receive chloroquine phosphate 450 mg every 12 hours orally Receives: Drug: Chloroquine Phosphate Tablets |
| Chloroquine plus losartan | Experimental | Patients will receive Chloroquine phosphate 450mg orally every 12hrs plus Losartan 25mg orally every 12hrs Receives: Drug: Chloroquine Phosphate Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall mortality
Determine all-cause mortality up to 28 days after randomization of Chloroquine Phosphate Compared to Chloroquine Phosphate plus Losartan in Non-Critically Ill Patients with SARS-CoV-2 Pneumonia.
Measured: 28 days
Secondary outcomes (3)
Clinical outcome assessment
Compare the clinical outcome of Chloroquine Phosphate treatment vs Chloroquine Phosphate plus Losartan in the follow-up visit at the end of treatment. Acording to NIH and FDA definitions
Measured: 28 days
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Assess the adverse events associated to chloroquine and chloroquine plus losartan at 28 days
Measured: 28 days
Time to negative SARS-CoV-2 test
Time to negative Polymerase chain reaction (PCR) test from baseline: testing every 48hrs until a negative result
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start10 Mar 2020
- Primary completion10 Jun 2020
- Study completion16 Feb 2021
Why it stopped: evidence showed chloroquine is not effective against COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 PneumoniaStudies 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
- Model description
- double blind randomized clinical trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Dr. Jose E. Gonzalez
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Adrian Camacho-Ortiz, Hospital Universitario Dr. Jose E. Gonzalez
- Investigators
- Adrian Camacho Ortiz, MD, Principal investigator, Hospital Universitario "Dr. Jose Eleuterio Gonzalez", UANL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04428268
- Sponsor's protocol ID
- IF20-00003
- Status last verified
- Feb 2021
- First submitted
- 26 Apr 2020
- Last updated
- 18 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II, Randomized, Double-blind, Controlled Clinical Trial Evaluating the Efficacy and Safety of Chloroquine + Low Dose Losartan Compared to Chloroquine Monotherapy in Subjects With SARS-CoV-2 Pneumonia
- ClinicalTrials.gov ID
- NCT04428268
- Acronym / sponsor ID
- IF20-00003
- Conditions
- COVID-19 Pneumonia
- Keywords
- COVID-19, SARS-CoV-2 pneumonia, Chloroquine phosphate, Losartan
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: evidence showed chloroquine is not effective against COVID-19
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hospital Universitario Dr. Jose E. GonzalezUniversity, hospital or other
- Study start
- 10 Mar 2020 (actual)
- Primary completion
- 10 Jun 2020 (actual)
- Study completion
- 16 Feb 2021 (actual)
- First posted
- 11 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.
Study design Phase 2, double blinded, single-center, 1:1 randomized clinical trial of Chloroquine vs Chloroquine/losartan for the treatment of SARS-CoV-2 pneumonia in non-critically ill subjects
Detailed description
Study design Phase 2, blinded, single-center, 1: 1 randomized clinical trial for the treatment of SARS-CoV-2 pneumonia in non-critically ill subjects. Two of the co-investigators and the data analyst will remain blind to group allocation until after statistical analysis.
The groups will consist of subjects receiving in one arm PO Chloroquine 450mg every 12 hours and in the other arm, in addition to chloroquine, PO Losartan 25mg every 24 hours. Study drugs will be administered for a total of 10 days enterally.
Baseline demographics and clinical characteristics will be registered and periodically during the study.
nasopharyngeal swabs will be taken every 48hrs during hospitalization to determine the presences and viral load of SARS-CoV-2, and daily EKG for QT interval monitoring.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- double blind randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Chloroquine | Active comparator | Drug: Chloroquine Phosphate TabletsPatients will receive chloroquine phosphate 450 mg every 12 hours orally |
| Chloroquine plus losartan | Experimental | Drug: Chloroquine Phosphate TabletsPatients will receive Chloroquine phosphate 450mg orally every 12hrs plus Losartan 25mg orally every 12hrs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men or women ≥18 years.
- Oral tolerance or access for enteral administration of medication.
- PCR or IgM for SARS-CoV-2 positive.
- Negative pregnancy test in case of a woman of reproductive age.
- Signature of a document proving informed consent.
Key exclusion criteria (17 listed)
- New alteration of the state of alert that does not revert after interventions 60 minutes after hospital admission.
- Mean Arterial Pressure (MAP) ≤ 65mmHg despite initial resuscitation on arrival at the centre.
- History of allergy to chloroquine, hydroxychloroquine, piperaquine or primaquine.
- Known patient with hearing loss.
- Received chloroquine or hydroxychloroquine in the last 3 months.
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 Phosphate TabletsAlso: Losartan tabletsOrally administered | Drug | Chloroquine, Chloroquine plus losartan |
Primary outcome
Overall mortality
Time frame: 28 days
Determine all-cause mortality up to 28 days after randomization of Chloroquine Phosphate Compared to Chloroquine Phosphate plus Losartan in Non-Critically Ill Patients with SARS-CoV-2 Pneumonia.
3 secondary outcomes
Clinical outcome assessment
Time frame: 28 days
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 28 days
Time to negative SARS-CoV-2 test
Time frame: 28 days
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 18 Feb 2021.
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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.
Adrian Camacho Ortiz, MD principal investigator
Hospital Universitario "Dr. Jose Eleuterio Gonzalez", UANL
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 Phosphate Tablets in people with COVID-19 Pneumonia, run by Hospital Universitario Dr. Jose E. Gonzalez at 1 site in Mexico.
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 6 inclusion and 17 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 18 Feb 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 Mexico. 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 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 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?
Overall mortality (time frame: 28 days). 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 18 Feb 2021.