- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04385836
Trial of Alpha One Antitrypsin Inhalation in Treating Patient With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Early Phase 1
Contacts and Locations
Study Contact
- Name: mohammed m othman
- Phone Number: 00966557881721
- Email: Ossman231@yahoo.com
Study Locations
-
-
-
Mecca, Saudi Arabia
- Recruiting
- Ministry of Health
-
Contact:
- mtair
- Phone Number: 0555509022
- Email: research-makkah@moh.gov.sa
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Positive RT-PCR) assay for SARS-CoV-2
- Age >18 years
- Hospitalized
- Able to give informed consent
Exclusion Criteria:
- Known allergy to AAT
- imminent death within next 24 hours
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: alpha one antitrypsin group
- 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
|
- 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
|
Placebo Comparator: placebo group
we will give 8 ml of normal saline as nebulizer every 12 hours for 5 days
|
- 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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 |
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.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: mohammed m othman, MOH
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Severe Acute Respiratory Syndrome
- Coronavirus Infections
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Protease Inhibitors
- Serine Proteinase Inhibitors
- Trypsin Inhibitors
- Alpha 1-Antitrypsin
- Protein C Inhibitor
Other Study ID Numbers
- 4-0520- 076-K-02-H
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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