SARS-CoV InfectionPhase 4NCT04340557
Do Angiotensin Receptor Blockers Mitigate Progression to Acute Respiratory Distress Syndrome With SARS-CoV-2 Infection
A Phase 4 study testing Losartan in people with SARS-CoV Infection, run by Sharp HealthCare at 3 sites in United States.
Trial summary
The purpose of this research is to identify whether or not Angiotensin Receptor Blockers (ARB) can halt the progression to respiratory failure requiring transfer into the intensive care unit (ICU), as well as halt mechanical ventilation in subjects with mild to moderate hypoxia due to the corona virus that causes… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SARS-CoV Infection
- What is being tested?
- Losartan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 3 sitesUnited States
- Study dates
- 27 Mar 2020to 13 Jun 2020
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Confirmed COVID-19 positive test result
- Mild to moderate respiratory symptoms of COVID-19.
- Systolic blood pressure ≥ 105 mmHg.
- Screen within 3 days of a positive COVID-19 test.
- Age ≥18 years old.
- Access to a phone in the hospital room or an electronic device that is capable of receiving phone or video calls.
Show all 9Show fewer
- Able to read/write/speak English or Spanish fluently.
- Subjects must have the capacity to provide consent or an appropriate LAR to provide informed consent.
- Negative pregnancy test for women of childbearing potential and subject is randomized to the study arm.
Who cannot join
- Severe allergy to any ARB or ACE-inhibitor, including angioedema
- In the intensive care unit at screening.
- Home meds include any kind of ACE inhibitor or ARB
- Acute Kidney Injury (50% reduction in GFR from baseline at admission to any time during treatment in the study treatment arm)
- Hyperkalemia >5.0 mmol/L at baseline or any time during treatment in the study treatment arm
- Creatinine Clearance < 30 ml/min at baseline or any time during treatment in the study treatment arm
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Sharp Grossmont Hospital
La Mesa, California, 91942
Sharp Chula Vista Medical Center
San Diego, California, 91911
Sharp Memorial Hospital
San Diego, California, 92123
About this study
Official title: Randomized Open Label Study of Standard of Care Plus an Angiotensin II Receptor Blocker Compared to Standard of Care Alone to Minimize the Progression to Respiratory Failure in SARS-CoV-2 Infection
The purpose of this research is to identify whether or not Angiotensin Receptor Blockers (ARB) can halt the progression to respiratory failure requiring transfer into the intensive care unit (ICU), as well as halt mechanical ventilation in subjects with mild to moderate hypoxia due to the corona virus that causes COVID-19. Based on previous animal studies, the researchers hypothesize that the addition of an ARB is beneficial in abating acute lung injury in subjects in early stages of SARS-CoV-2 viral induced hypoxia.
Read the detailed description
This is an investigator initiated, open label, multicenter, two arm, randomized study to compare the impact of adding an ARB to the Standard of Care (SOC) to the SOC without an ARB. Randomization ratio will be 1:1. The goal of this study is to identify whether or not ARBs have an impact on inhibiting the progression to respiratory failure requiring mechanical ventilation in patients with mild to moderate hypoxia in the setting of COVID-19. The addition of an ARB to the standard of care treatment for these patients may be beneficial in abating acute lung injury in patients in early stages of SARS-CoV-2 induced hypoxia.
- Conditions
- SARS-CoV Infection
- Being tested
- Losartan
- Keywords
- Coronavirus, Angiotensin receptor blocker, SARS-CoV-2, COVID-19
- Medical subject headings
- Severe Acute Respiratory Syndrome, Coronavirus Infections, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LosartanDrug
Also called Losartan + Standard of Care
Standard of care plus the starting dose of losartan 12.5mg (investigator has option to increase dose on days 2-10 based on tolerance of SBP) of losartan taken twice daily for up to 10 days. Upon the treating clinician's discretion, losartan may be continued beyond 10 days for non-COVID-19 indications.
| Study group | Role | What they receive |
|---|---|---|
| Group A (Study drug+SOC) | Experimental | Standard of Care plus an ARB to be taken orally twice daily for up to 10 days or until discharged from the hospital, whichever occurs first. Investigator may increase dose on days 2 - 10 if confident the subject will tolerate. Receives: Drug: Losartan |
| Group B (SOC) | No intervention | Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mechanical Ventilation
Number of subjects requiring transfer into ICU for mechanical ventilation due to respiratory failure
Measured: from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days
Secondary outcomes (2)
ICU Transfer
Number of subjects transferred from non-ICU bed to an ICU bed
Measured: from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days
Oxygen Therapy
Mean number of liters of oxygen consumed
Measured: from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2020
- Study start27 Mar 2020
- Primary completion13 Jun 2020
- Study completion13 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV InfectionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be randomized into one of two groups: Standard of Care or Standard of Care plus an ARB.
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sharp HealthCare
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Geriak, Sharp HealthCare
- Investigators
- Matthew Geriak, PharmD, Study director, Sharp HealthCare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04340557
- Sponsor's protocol ID
- COVID-ARB
- Other IDs
- 2003902
- Status last verified
- May 2021
- First submitted
- 6 Apr 2020
- Last updated
- 26 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Geriak M, Haddad F, Kullar R, Greenwood KL, Habib M, Habib C, Willms D, Sakoulas G. Randomized Prospective Open Label Study Shows No Impact on Clinical Outcome of Adding Losartan to Hospitalized COVID-19 Patients with Mild Hypoxemia. Infect Dis Ther. 2021 Sep;10(3):1323-1330. doi: 10.1007/s40121-021-00453-3. Epub 2021 May 11.
PubMed 33977506
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Open Label Study of Standard of Care Plus an Angiotensin II Receptor Blocker Compared to Standard of Care Alone to Minimize the Progression to Respiratory Failure in SARS-CoV-2 Infection
- ClinicalTrials.gov ID
- NCT04340557
- Acronym / sponsor ID
- COVID-ARB
- Conditions
- SARS-CoV Infection
- Keywords
- Coronavirus, Angiotensin receptor blocker, SARS-CoV-2, COVID-19
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Sharp HealthCareUniversity, hospital or other
- Study start
- 27 Mar 2020 (actual)
- Primary completion
- 13 Jun 2020 (actual)
- Study completion
- 13 Jun 2020 (actual)
- First posted
- 9 Apr 2020 (actual)
- Results
- Posted 26 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to identify whether or not Angiotensin Receptor Blockers (ARB) can halt the progression to respiratory failure requiring transfer into the intensive care unit (ICU), as well as halt mechanical ventilation in subjects with mild to moderate hypoxia due to the corona virus that causes COVID-19. Based on previous animal studies, the researchers hypothesize that the addition of an ARB is beneficial in abating acute lung injury in subjects in early stages of SARS-CoV-2 viral induced hypoxia.
Detailed description
This is an investigator initiated, open label, multicenter, two arm, randomized study to compare the impact of adding an ARB to the Standard of Care (SOC) to the SOC without an ARB. Randomization ratio will be 1:1. The goal of this study is to identify whether or not ARBs have an impact on inhibiting the progression to respiratory failure requiring mechanical ventilation in patients with mild to moderate hypoxia in the setting of COVID-19. The addition of an ARB to the standard of care treatment for these patients may be beneficial in abating acute lung injury in patients in early stages of SARS-CoV-2 induced hypoxia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects will be randomized into one of two groups: Standard of Care or Standard of Care plus an ARB.
| Arm | Type | Receives |
|---|---|---|
| Group A (Study drug+SOC) | Experimental | Drug: LosartanStandard of Care plus an ARB to be taken orally twice daily for up to 10 days or until discharged from the hospital, whichever occurs first. Investigator may increase dose on days 2 - 10 if confident the subject will tolerate. |
| Group B (SOC) | No intervention | –Standard of Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Confirmed COVID-19 positive test result
- Mild to moderate respiratory symptoms of COVID-19.
- Systolic blood pressure ≥ 105 mmHg.
- Screen within 3 days of a positive COVID-19 test.
- Age ≥18 years old.
Key exclusion criteria (6 listed)
- Severe allergy to any ARB or ACE-inhibitor, including angioedema
- In the intensive care unit at screening.
- Home meds include any kind of ACE inhibitor or ARB
- Acute Kidney Injury (50% reduction in GFR from baseline at admission to any time during treatment in the study treatment arm)
- Hyperkalemia >5.0 mmol/L at baseline or any time during treatment in the study treatment arm
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 |
|---|---|---|
| LosartanAlso: Losartan + Standard of CareStandard of care plus the starting dose of losartan 12.5mg (investigator has option to increase dose on days 2-10 based on tolerance of SBP) of losartan taken twice daily for up to 10 days. Upon the treating clinician's discretion, losartan may be continued beyond 10 days for non-COVID-19 indications. | Drug | Group A (Study drug+SOC) |
Primary outcome
Mechanical Ventilation
Time frame: from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days
Number of subjects requiring transfer into ICU for mechanical ventilation due to respiratory failure
2 secondary outcomes
ICU Transfer
Time frame: from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days
Oxygen Therapy
Time frame: from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33977506Geriak M, Haddad F, Kullar R, Greenwood KL, Habib M, Habib C, Willms D, Sakoulas G. Randomized Prospective Open Label Study Shows No Impact on Clinical Outcome of Adding Losartan to Hospitalized COVID-19 Patients with Mild Hypoxemia. Infect Dis Ther. 2021 Sep;10(3):1323-1330. doi: 10.1007/s40121-021-00453-3. Epub 2021 May 11.
- 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.
Matthew Geriak, PharmD study director
Sharp HealthCare
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 Losartan in people with SARS-CoV Infection, run by Sharp HealthCare at 3 sites 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 9 inclusion and 6 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 26 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 3 sites 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. 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?
Yes. Results are posted in the registry (first posted 26 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mechanical Ventilation (time frame: from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days). 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 NCT04340557, 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 26 May 2021.