Coronavirus InfectionsNCT04435106
Compassionate Use of Opaganib in Patients With Coronavirus Disease 2019 (COVID-19)
An observational study of Coronavirus Infections, run by Shaare Zedek Medical Center at 1 site in Israel.
Trial summary
Shaare-Zedek Medical Center is a tertiary academic hospital in Jerusalem, Israel. On March 2020, a dramatic increase in the number of COVID-19 cases were diagnosed in Jerusalem. RedHill Biopharma, Ltd. offered opaganib under compassionate use for the treatment of COVID-19 patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronavirus Infections
- What is being tested?
- Opaganib
- Type of treatment
- Pill or oral medicine
- How many people
- 23 participants
- Where
- 1 siteIsrael
- Study dates
- 3 Apr 2020to 15 May 2020
- Phase
- Observational
- 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 to 80 years
- All sexes
- Adult, Older adult
Study population: Patients with severe COVID-19 who required oxygen support via high-flow nasal cannula (HFNC)
Who may be able to join
- hospitalized patients with COVID-19 confirmed by a reverse-transcriptase-polymerase-chain-reaction assay
- patients with severe disease requiring oxygen support via high-flow nasal cannula
- signed informed consent
- acceptable liver and renal function tests
- acceptable hematologic status
Who cannot join
- pregnant or nursing women
- patients on warfarin, apixaban, argatroban or rivaroxaban
- patients with New York Heart Association Class III or IV cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia, or evidence of ischemia on ECG
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Compassionate Use of Opaganib in Patients With Severe COVID-19
Shaare-Zedek Medical Center is a tertiary academic hospital in Jerusalem, Israel. On March 2020, a dramatic increase in the number of COVID-19 cases were diagnosed in Jerusalem. RedHill Biopharma, Ltd. offered opaganib under compassionate use for the treatment of COVID-19 patients. Eligible patients were those hospitalized with COVID-19 confirmed by a reverse-transcriptase-polymerase-chain-reaction assay. Patients received opaganib and Standard of Care. For the purpose of this study, the opaganib and Standard of Care patient group was compared to a group of patients that received only Standard of Care. Opaganib is an investigational drug under development and not approved for commercial distribution.
Read the detailed description
In this observational study, the two cohorts were assigned retrospectively. Patients either received opaganib and Standard of Care (SOC) or SOC only. All patients were defined by the treating physicians at baseline as severe COVID-19. For the control cohort, IRB approval was granted to collect de-identified data. Both cohorts had similar median age and similar rates of diabetes, hypertension and obesity.
The two treatment groups, opaganib and SOC vs. SOC were then analyzed for their clinical outcomes including baseline characteristics.
- Conditions
- Coronavirus Infections
- Being tested
- Opaganib, Standard of Care
- Medical subject headings
- Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OpaganibDrug
Also called Yeliva, ABC294640
Study participants received opaganib 2 x 250 mg capsules (500 mg) every 12 hours in addition to Standard of Care
Standard of CareDrug
Study participants received Standard of Care
| Study group | Role | What they receive |
|---|---|---|
| Opaganib + Standard of Care | Study participants received opaganib 2 x 250 mg capsules (500 mg) every 12 hours in addition to Standard of Care Receives: Drug: Opaganib; Drug: Standard of Care | |
| Standard of Care | Study participants received Standard of Care Receives: Drug: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure the time to weaning from high-flow nasal cannula
Measured: Every day from day 1 to day 14
Measure the time to breathing ambient (room) air
Measured: Every day from day 1 to day 14
Secondary outcomes (2)
Measure change in lymphocyte count
Measured: On day of admission or day 1 of treatment and every 2-4 days, till day 14
Measure change in C-reactive protein
Measured: On day of admission or day 1 of treatment and every 2-4 days, till day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2020
- Study start3 Apr 2020
- Primary completion1 May 2020
- Study completion15 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronavirus InfectionsStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04435106
- Sponsor's protocol ID
- 0123-20- SZMC
- Status last verified
- Jun 2020
- First submitted
- 26 May 2020
- Last updated
- 17 Jun 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compassionate Use of Opaganib in Patients With Severe COVID-19
- ClinicalTrials.gov ID
- NCT04435106
- Acronym / sponsor ID
- 0123-20- SZMC
- Conditions
- Coronavirus Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Study start
- 3 Apr 2020 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 15 May 2020 (actual)
- First posted
- 17 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.
Shaare-Zedek Medical Center is a tertiary academic hospital in Jerusalem, Israel. On March 2020, a dramatic increase in the number of COVID-19 cases were diagnosed in Jerusalem. RedHill Biopharma, Ltd. offered opaganib under compassionate use for the treatment of COVID-19 patients. Eligible patients were those hospitalized with COVID-19 confirmed by a reverse-transcriptase-polymerase-chain-reaction assay. Patients received opaganib and Standard of Care. For the purpose of this study, the opaganib and Standard of Care patient group was compared to a group of patients that received only Standard of Care. Opaganib is an investigational drug under development and not approved for commercial distribution.
Detailed description
In this observational study, the two cohorts were assigned retrospectively. Patients either received opaganib and Standard of Care (SOC) or SOC only. All patients were defined by the treating physicians at baseline as severe COVID-19. For the control cohort, IRB approval was granted to collect de-identified data. Both cohorts had similar median age and similar rates of diabetes, hypertension and obesity.
The two treatment groups, opaganib and SOC vs. SOC were then analyzed for their clinical outcomes including baseline characteristics.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Opaganib + Standard of Care | – | Drug: Opaganib, Drug: Standard of CareStudy participants received opaganib 2 x 250 mg capsules (500 mg) every 12 hours in addition to Standard of Care |
| Standard of Care | – | Drug: Standard of CareStudy participants received Standard of Care |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with severe COVID-19 who required oxygen support via high-flow nasal cannula (HFNC)
Key inclusion criteria (5 listed)
- hospitalized patients with COVID-19 confirmed by a reverse-transcriptase-polymerase-chain-reaction assay
- patients with severe disease requiring oxygen support via high-flow nasal cannula
- signed informed consent
- acceptable liver and renal function tests
- acceptable hematologic status
Key exclusion criteria (3 listed)
- pregnant or nursing women
- patients on warfarin, apixaban, argatroban or rivaroxaban
- patients with New York Heart Association Class III or IV cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia, or evidence of ischemia on ECG
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 |
|---|---|---|
| OpaganibAlso: Yeliva, ABC294640Study participants received opaganib 2 x 250 mg capsules (500 mg) every 12 hours in addition to Standard of Care | Drug | Opaganib + Standard of Care |
| Standard of CareStudy participants received Standard of Care | Drug | Opaganib + Standard of Care, Standard of Care |
Primary outcome
Measure the time to weaning from high-flow nasal cannula
Time frame: Every day from day 1 to day 14
Measure the time to breathing ambient (room) air
Time frame: Every day from day 1 to day 14
2 secondary outcomes
Measure change in lymphocyte count
Time frame: On day of admission or day 1 of treatment and every 2-4 days, till day 14
Measure change in C-reactive protein
Time frame: On day of admission or day 1 of treatment and every 2-4 days, till day 14
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 17 Jun 2020.
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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?
An observational study of Coronavirus Infections, run by Shaare Zedek Medical Center at 1 site in Israel.
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 5 inclusion and 3 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 17 Jun 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 Israel. 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.
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?
Measure the time to weaning from high-flow nasal cannula (time frame: Every day from day 1 to day 14). The study lists 2 primary outcomes in all. 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 17 Jun 2020.