COVID-19Phase 2NCT04363866
Assessing Hydroxychloroquine in Patients With SARS-CoV-2 (COVID-19)
A Phase 2 study testing Hydroxychloroquine in people with COVID-19 and SARS-CoV-2, run by Oregon Health and Science University at 1 site in United States.
Trial summary
This is a prospective, randomized, double-blinded, placebo-controlled, pilot study to assess the preliminary efficacy and safety of hydroxychloroquine for the treatment of patients with lower respiratory tract SARS-CoV-2 infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, SARS-CoV-2
- What is being tested?
- Hydroxychloroquine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2020to Sep 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
- Ability to understand and the willingness to sign a written informed consent document.
- Individuals aged ≥ 18 years of all races and ethnic groups.
- Must have documented positive test result for SARS-CoV-2 (COVID19), or high clinical suspicion for SARS-CoV-2 based on presence of typical clinical findings (e.g., fever, respiratory symptoms, pulmonary abnormalities on chest X-ray or CT scan), lack of alternative diagnosis, and history of exposure to a known case of SARS-CoV- 2 infection within the past 14 days
- Not receiving institutional therapy for treatment of SARS-CoV-2, including (but not limited to) remdesivir, chloroquine, hydroxychloroquine, or any other investigational agent(s).
- Must meet at least one of the following clinical stratifications:
- Have at least 1 minor criterion per ATS criteria (refer to Appendix A), or
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- Have fever, respiratory symptoms, with pneumonia visible on chest imaging (e.g., X-ray or computed tomography [CT]), or
- High risk for poor outcome, as defined by any one of the following:
- Age ≥ 60 years old ii. Underlying medical comorbidities, defined as:
- Serious cardiovascular disease
- Poorly controlled diabetes (i.e., A1c levels >7%)
- Chronic kidney disease requiring dialysis
- Significant liver disease (Pugh-Child B or C)
- Severe obesity (body mass index [BMI] ≥ 40)
- Chronic respiratory disease (e.g., COPD)
- Hypertension, defined as blood pressure ≥ 140 / 90 mmHg iii. Solid organ or stem cell transplant recipient iv. Diagnosis of solid or hematologic malignancy being treated with systemic chemotherapy v. Receipt of biologic agent or prednisone > 0.5 mg/kg/day (or equivalent)
- Patient must be within 5 days of symptom onset, as determined by clinical team.
- Participants with preexisting auditory damage are allowed.
- Participants with a history of epilepsy are allowed.
- Female participants of childbearing potential (FOCBP) must have a negative serum or urine pregnancy test (per institutional standards) prior to the start of study drug.
- FOCBP must agree to use highly-effective method(s) of contraception (Appendix B) during the study and for 1 months after the last dose of study drug. FOCBP are those who have not been surgically sterilized or have not been free from menses for >1 year without an alternative medical cause.
- Male participants must agree to use an adequate method of contraception (Appendix B) starting with the first dose of study therapy through at least 1 months after the last dose of study drug.
- Participant must agree to not breastfeed during the study or for 30 days after the last dose of study treatment.
Who cannot join
- The patient has serious and/or uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study.
- Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements.
- Psychiatric illness/social situations, or any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of participant safety or study results, or substantially increase risk of incurring AEs, or compromise the ability of the patient to give written informed consent.
- Resting ECG indicating uncontrolled, potentially reversible cardiac conditions, as judged by the investigator (e.g., unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, QTcF prolongation >500 ms, electrolyte disturbances, etc.), or participants with congenital long QT syndrome
- Patients with Myesthenia Gravis or other neuromuscular disorders
- Patients with history of psoriasis.
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- May be waived at the discretion of the PI
- Patients with history of porphyria
- May be waived at the discretion of the PI
- Concomitant use of other antiviral agents for the study's duration, but may be waived at discretion of the Principal Investigator
- Hypersensitivity to the study agent, or any of its excipients.
- Females who are pregnant or lactating.
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health and Science University
Portland, Oregon, 97239
About this study
Official title: A Randomized-Control Pilot Study to Assess Hydroxychloroquine in Patients Infected With SARS-CoV-2 (COVID-19)
This is a prospective, randomized, double-blinded, placebo-controlled, pilot study to assess the preliminary efficacy and safety of hydroxychloroquine for the treatment of patients with lower respiratory tract SARS-CoV-2 infection.
Read the detailed description
A total of 40 participants are planned for enrollment. Those enrolled into this study will be randomized 1:1 to receive either hydroxychloroquine or placebo control.
Participants will receive their study intervention for 5 days, after which they will be considered off protocol- directed therapy and receive medical management of their disease according to institutional standards. Participants may be followed for up to 180 days from initiating protocol therapy for clinical outcome, after which they will discontinue study participation.
- Conditions
- COVID-19, SARS-CoV-2
- Being tested
- Hydroxychloroquine, Placebo
- Keywords
- SARS-CoV-2, COVID-19, Hydroxychloroquine, Coronavirus
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydroxychloroquine is more polar, less lipophilic, and has more difficulty diffusing across cell membranes than the parent compound, chloroquine. These characteristics result in hydroxychloroquine having a longer half-life, comparatively lower toxicity to chloroquine, as well as fewer concerns pertaining to drug-drug interactions
PlaceboDrug
A placebo is a pill that looks like the study drug but has no real medicine in it.
| Study group | Role | What they receive |
|---|---|---|
| Hydroxychloroquine | Experimental | 400 mg bid (PO) Day 1, followed by 200 mg bid (PO) Day 2 through Day 5 Receives: Drug: Hydroxychloroquine |
| Placebo | Placebo comparator | Placebo pill bid (PO) Day 1 through Day 5 of the treatment period Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Status at Day 5 Assessed by a 6-Point Ordinal Scale
A 6-point ordinal scale ranging from "Death" to "Not hospitalized with full resumption of normal activities" is used to evaluate differences in the clinical status between participants that receive placebo vs hydroxychloroquine
Measured: Day 5
Secondary outcomes (2)
Number of Participants with Detectable SARS-CoV-2 Virus from Day 0 to Day 28 and at Day 5
Assess differences in SARS-CoV-2 viral shedding between participants that receive placebo vs hydroxychloroquine
Measured: Day 0 to Day 28 and at Day 5
Toxicity of Study Drug Assessed by Incidence of Adverse Events
Assess by incidence of Grade 3, Grade 4, and Serious Adverse Events (AEs)
Measured: Day 0 to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2020
- Study startAug 2020 (estimated)
- Primary completionMar 2021 (estimated)
- Study completionSep 2021 (estimated)
Why it stopped: discontinued in favor of more promising directions that may benefit patients
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.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- OHSU Knight Cancer Institute
- Responsible party
- Principal investigator, Marcel Curlin, Oregon Health and Science University
- Investigators
- Marcel Curlin, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04363866
- Sponsor's protocol ID
- STUDY00021303
- Status last verified
- Oct 2020
- First submitted
- 24 Apr 2020
- Last updated
- 29 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after the identification
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized-Control Pilot Study to Assess Hydroxychloroquine in Patients Infected With SARS-CoV-2 (COVID-19)
- ClinicalTrials.gov ID
- NCT04363866
- Acronym / sponsor ID
- STUDY00021303
- Conditions
- COVID-19, SARS-CoV-2
- Keywords
- SARS-CoV-2, COVID-19, Hydroxychloroquine, Coronavirus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: discontinued in favor of more promising directions that may benefit patients
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- OHSU Knight Cancer Institute
- Study start
- Aug 2020 (estimated)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 27 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 prospective, randomized, double-blinded, placebo-controlled, pilot study to assess the preliminary efficacy and safety of hydroxychloroquine for the treatment of patients with lower respiratory tract SARS-CoV-2 infection.
Detailed description
A total of 40 participants are planned for enrollment. Those enrolled into this study will be randomized 1:1 to receive either hydroxychloroquine or placebo control.
Participants will receive their study intervention for 5 days, after which they will be considered off protocol- directed therapy and receive medical management of their disease according to institutional standards. Participants may be followed for up to 180 days from initiating protocol therapy for clinical outcome, after which they will discontinue study participation.
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 |
|---|---|---|
| Hydroxychloroquine | Experimental | Drug: Hydroxychloroquine400 mg bid (PO) Day 1, followed by 200 mg bid (PO) Day 2 through Day 5 |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo pill bid (PO) Day 1 through Day 5 of the treatment period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Ability to understand and the willingness to sign a written informed consent document.
- Individuals aged ≥ 18 years of all races and ethnic groups.
- Must have documented positive test result for SARS-CoV-2 (COVID19), or high clinical suspicion for SARS-CoV-2 based on presence of typical clinical findings (e.g., fever, respiratory symptoms, pulmonary abnormalities on chest X-ray or CT scan), lack of alternative diagnosis, and history of exposure to a known case of SARS-CoV- 2 infection within the past 14 days
- Not receiving institutional therapy for treatment of SARS-CoV-2, including (but not limited to) remdesivir, chloroquine, hydroxychloroquine, or any other investigational agent(s).
- Must meet at least one of the following clinical stratifications:
Key exclusion criteria (12 listed)
- The patient has serious and/or uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study.
- Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements.
- Psychiatric illness/social situations, or any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of participant safety or study results, or substantially increase risk of incurring AEs, or compromise the ability of the patient to give written informed consent.
- Resting ECG indicating uncontrolled, potentially reversible cardiac conditions, as judged by the investigator (e.g., unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, QTcF prolongation >500 ms, electrolyte disturbances, etc.), or participants with congenital long QT syndrome
- Patients with Myesthenia Gravis or other neuromuscular disorders
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 |
|---|---|---|
| HydroxychloroquineHydroxychloroquine is more polar, less lipophilic, and has more difficulty diffusing across cell membranes than the parent compound, chloroquine. These characteristics result in hydroxychloroquine having a longer half-life, comparatively lower toxicity to chloroquine, as well as fewer concerns pertaining to drug-drug interactions | Drug | Hydroxychloroquine |
| PlaceboA placebo is a pill that looks like the study drug but has no real medicine in it. | Drug | Placebo |
Primary outcome
Clinical Status at Day 5 Assessed by a 6-Point Ordinal Scale
Time frame: Day 5
A 6-point ordinal scale ranging from "Death" to "Not hospitalized with full resumption of normal activities" is used to evaluate differences in the clinical status between participants that receive placebo vs hydroxychloroquine
2 secondary outcomes
Number of Participants with Detectable SARS-CoV-2 Virus from Day 0 to Day 28 and at Day 5
Time frame: Day 0 to Day 28 and at Day 5
Toxicity of Study Drug Assessed by Incidence of Adverse Events
Time frame: Day 0 to Day 28
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 29 Oct 2020.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after the identification
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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.
Marcel Curlin, MD principal investigator
Oregon Health and Science University
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 Hydroxychloroquine in people with COVID-19 and SARS-CoV-2, run by Oregon Health and Science University at 1 site in United States.
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 23 inclusion and 12 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 29 Oct 2020. 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 United States. 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 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?
Clinical Status at Day 5 Assessed by a 6-Point Ordinal Scale (time frame: Day 5). 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 29 Oct 2020; AzTrials last refreshed its copy on 6 Nov 2026.