CoronavirusEarly Phase 1NCT04385836
Trial of Alpha One Antitrypsin Inhalation in Treating Patient With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
A Early Phase 1 study testing alpha one antitrypsin inhalation in people with Coronavirus, run by Ministry of Health, Saudi Arabia at 1 site in Saudi Arabia.
Trial summary
It is clear now that SARS-CoV-2 could use angiotensin-converting enzyme 2 (ACE2), the same receptor as SARS-CoV Transmembrane protease serine type 2 (TMPRSS2), a protease belonging to the type II transmembrane serine protease family, cleaves the coronavirus spike protein Serine proteases are inhibited by a diverse… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronavirus
- What is being tested?
- alpha one antitrypsin inhalation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Jun 2020to 1 Sep 2020
- Phase
- Early Phase 1
- 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
- Positive RT-PCR) assay for SARS-CoV-2
- Age >18 years
- Hospitalized
- Able to give informed consent
Who cannot join
- Known allergy to AAT
- imminent death within next 24 hours
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site, 1 recruiting
- Recruiting
Ministry of Health
Mecca
mtair, 0555509022, research-makkah@moh.gov.sa
About this study
It is clear now that SARS-CoV-2 could use angiotensin-converting enzyme 2 (ACE2), the same receptor as SARS-CoV Transmembrane protease serine type 2 (TMPRSS2), a protease belonging to the type II transmembrane serine protease family, cleaves the coronavirus spike protein Serine proteases are inhibited by a diverse group of inhibitors, The best-studied serpins are antithrombin and alpha 1-antitrypsin
- Conditions
- Coronavirus
- Being tested
- alpha one antitrypsin inhalation
- Medical subject headings
- Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alpha one antitrypsin inhalationDrug
- we will give 8 ml of intravenous alpha one antitrypsin (alpha1-proteinase inhibitor (AATD)Glassia 50 ml) as nebulizer every 12 hours for 5 days
| Study group | Role | What they receive |
|---|---|---|
| alpha one antitrypsin group | Active comparator | - we will give 8 ml of intravenous alpha one antitrypsin (alpha1-proteinase inhibitor (AATD)Glassia 50 ml) add to 2cm of normal saline solution as nebulizer every 12 hours for 5 days Receives: Drug: alpha one antitrypsin inhalation |
| placebo group | Placebo comparator | we will give 8 ml of normal saline as nebulizer every 12 hours for 5 days Receives: Drug: alpha one antitrypsin inhalation |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical improvement
Time to clinical improvement, from the point of randomization to two-point improvement on a seven-point ordinal scale or discharged alive from hospital, whichever comes first.
Ordinal Scale - 1, Ambulatory with normal activities; 2, Ambulatory with limitation of normal activities; 3, not requiring supplemental oxygen; 4, requiring supplemental oxygen by mask or nasal prongs; 5, requiring nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both; 6, requiring ECMO, invasive mechanical ventilation, or both; and 7, death
Measured: we will follow the patient daily starting from the day 0 which is the first day of giving drug for 3 weeks or till clinical improvement and discharge from the hospital or till death whichever comes first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2020
- Study start1 Jun 2020 (estimated)
- Primary completion1 Sep 2020 (estimated)
- Study completion1 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoronavirusStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ministry of Health, Saudi Arabia
- Sponsor type
- Other government
- Responsible party
- Principal investigator, mohamed mahmoud mohamed othman, Ministry of Health, Saudi Arabia
- Investigators
- mohammed m othman, Principal investigator, MOH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04385836
- Sponsor's protocol ID
- 4-0520- 076-K-02-H
- Status last verified
- May 2020
- First submitted
- 10 May 2020
- Last updated
- 13 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of Alpha One Antitrypsin Inhalation in Treating Patient With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
- ClinicalTrials.gov ID
- NCT04385836
- Acronym / sponsor ID
- 4-0520- 076-K-02-H
- Conditions
- Coronavirus
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Ministry of Health, Saudi ArabiaOther government
- Study start
- 1 Jun 2020 (estimated)
- Primary completion
- 1 Sep 2020 (estimated)
- Study completion
- 1 Sep 2020 (estimated)
- First posted
- 13 May 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.
It is clear now that SARS-CoV-2 could use angiotensin-converting enzyme 2 (ACE2), the same receptor as SARS-CoV Transmembrane protease serine type 2 (TMPRSS2), a protease belonging to the type II transmembrane serine protease family, cleaves the coronavirus spike protein Serine proteases are inhibited by a diverse group of inhibitors, The best-studied serpins are antithrombin and alpha 1-antitrypsin
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| alpha one antitrypsin group | Active comparator | Drug: alpha one antitrypsin inhalation- we will give 8 ml of intravenous alpha one antitrypsin (alpha1-proteinase inhibitor (AATD)Glassia 50 ml) add to 2cm of normal saline solution as nebulizer every 12 hours for 5 days |
| placebo group | Placebo comparator | Drug: alpha one antitrypsin inhalationwe will give 8 ml of normal saline as nebulizer every 12 hours for 5 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Positive RT-PCR) assay for SARS-CoV-2
- Age >18 years
- Hospitalized
- Able to give informed consent
Key exclusion criteria (2 listed)
- Known allergy to AAT
- imminent death within next 24 hours
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 |
|---|---|---|
| alpha one antitrypsin inhalation- we will give 8 ml of intravenous alpha one antitrypsin (alpha1-proteinase inhibitor (AATD)Glassia 50 ml) as nebulizer every 12 hours for 5 days | Drug | alpha one antitrypsin group, placebo group |
Primary outcome
clinical improvement
Time frame: we will follow the patient daily starting from the day 0 which is the first day of giving drug for 3 weeks or till clinical improvement and discharge from the hospital or till death whichever comes first.
Time to clinical improvement, from the point of randomization to two-point improvement on a seven-point ordinal scale or discharged alive from hospital, whichever comes first. Ordinal Scale - 1, Ambulatory with normal activities; 2, Ambulatory with limitation of normal activities; 3, not requiring supplemental oxygen; 4, requiring supplemental oxygen by mask or nasal prongs; 5, requiring nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both; 6, requiring ECMO, invasive mechanical ventilation, or both; and 7, death
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2020.
- Individual participant dataSharing planned: Yes
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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.
mohammed m othman principal investigator
MOH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing alpha one antitrypsin inhalation in people with Coronavirus, run by Ministry of Health, Saudi Arabia at 1 site in Saudi Arabia.
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 2 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: status not confirmed, as of the sponsor's last update on 13 May 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 Saudi Arabia. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact mohammed m othman (00966557881721, Ossman231@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical improvement (time frame: we will follow the patient daily starting from the day 0 which is the first day of giving drug for 3 weeks or till clinical improvement and discharge from the hospital or till death whichever comes first.). 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 13 May 2020.