SARS-CoV-2Phase 4PEACENCT04346667
Post-Exposure Prophylaxis for Asymptomatic SARS-CoV-2 COVID-19 Patients With choloroquinE Compounds
A Phase 4 study testing Hydroxychloroquine Sulfate Regular dose, Hydroxychloroquine Sulfate Loading Dose and Chloroquine in people with SARS-CoV-2 and Coronavirus Infection, run by Government of Punjab, Specialized Healthcare and Medical Education Department at 3 sites in Pakistan.
Trial summary
To create a protocol for treatment of Pakistani patients with SARS-CoV-2 infection with an intent to reduce burden on institutional healthcare services by determining efficacy of different quinone drug dosing regimens in controlling SARS-CoV-2 infection for asymptomatic patients. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- SARS-CoV-2, Coronavirus Infection, Asymptomatic Condition
- What is being tested?
- Hydroxychloroquine Sulfate Regular dose, Hydroxychloroquine Sulfate Loading Dose and Chloroquine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 125 participants
- Where
- 3 sitesPakistan
- Study dates
- 14 Apr 2020to 30 Aug 2020
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Nasopharyngeal RT-PCR positive SARS-CoV-2 patient
- Age 20-50 years
- BMI 18-28 kg/m2
- Informed consent
Who cannot join
- Symptoms: Cough, fever, shortness of breath
- O2 saturation by pulse-oximeter below 94%
- Co-morbidities: any pre-existing cardiac disease, pulmonary disease, diabetes
- Arrhythmias and/or history of arrythmia
- Psoriasis and/or history of psoriasis
- Neuropathy or myopathy and/or history of these
Show all 13Show fewer
- Hypoglycemia and/or history of hypoglycemia
- Pre-existing hepatic disease
- Pre-existing renal disease
- Use of antacids within 1 week
- Use of antibiotics within 1 week
- Pregnancy
- RT-PCR performed >3 days prior to enrollment
Trial locations and contacts
3 sites in 1 country.
Pakistan3 sites
Expo Covid Center
Lahore, Punjab Province
Mayo Hospital
Lahore, Punjab Province
Pakistan Kidney and Liver Institute
Lahore, Punjab Province
About this study
Official title: Use and Dosage of Hydroxychloroquine and Chloroquine to Convert Real Time Polymerase Chain Reaction (RT-PCR) Positive Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Coronavirus Infectious Disease 2019 (COVID-19) Patients to RT- PCR-Negative as a Means to Reduce Hospitalization Rate
To create a protocol for treatment of Pakistani patients with SARS-CoV-2 infection with an intent to reduce burden on institutional healthcare services by determining efficacy of different quinone drug dosing regimens in controlling SARS-CoV-2 infection for asymptomatic patients.
- Conditions
- SARS-CoV-2, Coronavirus Infection, Asymptomatic Condition, COVID-19
- Being tested
- Hydroxychloroquine Sulfate Regular dose, Hydroxychloroquine Sulfate Loading Dose, Chloroquine, Placebo
- Medical subject headings
- Coronavirus Infections, Asymptomatic Diseases, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydroxychloroquine Sulfate Regular doseDrug
Hydroxychloroquine administered based off of in-vitro pharmacokinetics study of optimal dosage for efficacy against SARS-CoV-2
Hydroxychloroquine Sulfate Loading DoseDrug
Hydroxychloroquine administered as a loading dose only
ChloroquineDrug
Chloroquine administered based off of in-vitro pharmacokinetics study of optimal dosage for efficacy against SARS-CoV-2
PlaceboDrug
Standard of Care plus placebo
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | Hydroxychloroquine loading dose (400 mg BID for 2 days) followed by 200 mg BID for 4 days plus standard of care Receives: Drug: Hydroxychloroquine Sulfate Regular dose |
| Arm 2 | Experimental | Hydroxychloroquine loading dose (400 mg BID) alone plus standard of care Receives: Drug: Hydroxychloroquine Sulfate Loading Dose |
| Arm 3 | Active comparator | Chloroquine 500 mg BID for 5 days plus standard of care Receives: Drug: Chloroquine |
| Arm 4 | Placebo comparator | Standard of care plus placebo (cannot be treated with hydroxychloroquine or chloroquine) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
RT-PCR negative status
Percentage of patients who become RT-PCR negative with two RT-PCR tests performed at day 6 and day 7
Measured: 6-7 days
Secondary outcomes (3)
Progression of symptoms
Time to progression to next stage of SARS-CoV-2 disease severity index
Measured: 7 days
Development of Symptoms
Time to onset of fever (temperature greater than 100 degree F), cough, or shortness of breath (respiratory rate >22 per minute).
Measured: 7 days
Adverse events
Drug related adverse events as determined by data safety and monitoring board (DSMB)
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2020
- Study start14 Apr 2020
- Primary completion23 Aug 2020
- Study completion30 Aug 2020
Why it stopped: Poor accrual.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Government of Punjab, Specialized Healthcare and Medical Education Department
- Sponsor type
- Other government
- Collaborators
- Mayo Hospital Lahore, Services Institute of Medical Sciences, Pakistan, Pakistan Kidney and Liver Institute, Forman Christian College, Pakistan, Harvard School of Public Health (HSPH)
- Responsible party
- Principal investigator, Ammar Sarwar, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04346667
- Sponsor's protocol ID
- NBC-COVID19-02
- Acronym
- PEACE
- Status last verified
- Mar 2021
- First submitted
- 13 Apr 2020
- Last updated
- 10 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use and Dosage of Hydroxychloroquine and Chloroquine to Convert Real Time Polymerase Chain Reaction (RT-PCR) Positive Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Coronavirus Infectious Disease 2019 (COVID-19) Patients to RT- PCR-Negative as a Means to Reduce Hospitalization Rate
- ClinicalTrials.gov ID
- NCT04346667
- Acronym / sponsor ID
- PEACE / NBC-COVID19-02
- Conditions
- SARS-CoV-2, Coronavirus Infection, Asymptomatic Condition, COVID-19
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor accrual.
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Government of Punjab, Specialized Healthcare and Medical Education DepartmentOther government
- Collaborators
- Mayo Hospital Lahore, Services Institute of Medical Sciences, Pakistan, Pakistan Kidney and Liver Institute, Forman Christian College, Pakistan, Harvard School of Public Health (HSPH)
- Study start
- 14 Apr 2020 (actual)
- Primary completion
- 23 Aug 2020 (actual)
- Study completion
- 30 Aug 2020 (actual)
- First posted
- 15 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.
To create a protocol for treatment of Pakistani patients with SARS-CoV-2 infection with an intent to reduce burden on institutional healthcare services by determining efficacy of different quinone drug dosing regimens in controlling SARS-CoV-2 infection for asymptomatic patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Drug: Hydroxychloroquine Sulfate Regular doseHydroxychloroquine loading dose (400 mg BID for 2 days) followed by 200 mg BID for 4 days plus standard of care |
| Arm 2 | Experimental | Drug: Hydroxychloroquine Sulfate Loading DoseHydroxychloroquine loading dose (400 mg BID) alone plus standard of care |
| Arm 3 | Active comparator | Drug: ChloroquineChloroquine 500 mg BID for 5 days plus standard of care |
| Arm 4 | Placebo comparator | Drug: PlaceboStandard of care plus placebo (cannot be treated with hydroxychloroquine or chloroquine) |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Nasopharyngeal RT-PCR positive SARS-CoV-2 patient
- Age 20-50 years
- BMI 18-28 kg/m2
- Informed consent
Key exclusion criteria (13 listed)
- Symptoms: Cough, fever, shortness of breath
- O2 saturation by pulse-oximeter below 94%
- Co-morbidities: any pre-existing cardiac disease, pulmonary disease, diabetes
- Arrhythmias and/or history of arrythmia
- Psoriasis and/or history of psoriasis
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 |
|---|---|---|
| Hydroxychloroquine Sulfate Regular doseHydroxychloroquine administered based off of in-vitro pharmacokinetics study of optimal dosage for efficacy against SARS-CoV-2 | Drug | Arm 1 |
| Hydroxychloroquine Sulfate Loading DoseHydroxychloroquine administered as a loading dose only | Drug | Arm 2 |
| ChloroquineChloroquine administered based off of in-vitro pharmacokinetics study of optimal dosage for efficacy against SARS-CoV-2 | Drug | Arm 3 |
| PlaceboStandard of Care plus placebo | Drug | Arm 4 |
Primary outcome
RT-PCR negative status
Time frame: 6-7 days
Percentage of patients who become RT-PCR negative with two RT-PCR tests performed at day 6 and day 7
3 secondary outcomes
Progression of symptoms
Time frame: 7 days
Development of Symptoms
Time frame: 7 days
Adverse events
Time frame: 7 days
Results and safety
The study was stopped early (reason given: Poor accrual.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
- Individual participant dataSharing planned: No
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hydroxychloroquine Sulfate Regular dose, Hydroxychloroquine Sulfate Loading Dose and Chloroquine in people with SARS-CoV-2 and Coronavirus Infection, run by Government of Punjab, Specialized Healthcare and Medical Education Department at 3 sites in Pakistan.
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 13 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: stopped early, as of the sponsor's last update on 10 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Pakistan. 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 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 stopped early (reason given: Poor accrual.). Results are not available in the source record.
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?
RT-PCR negative status (time frame: 6-7 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 10 Mar 2021.