Back to resultsTrial of Alpha One Antitrypsin Inhalation in Treating Patient With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
Primary Purpose
Coronavirus
Status
Unknown status
Phase
Early Phase 1
Locations
Saudi Arabia
Study Type
Interventional
Intervention
alpha one antitrypsin inhalation
Sponsored by
About this trial
This is an interventional treatment trial for Coronavirus
Eligibility Criteria
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
Sites / Locations
- Ministry of HealthRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
alpha one antitrypsin group
placebo group
Arm Description
- 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 normal saline as nebulizer every 12 hours for 5 days
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT04385836
First Posted
May 10, 2020
Last Updated
May 12, 2020
Sponsor
Ministry of Health, Saudi Arabia
1. Study Identification
Unique Protocol Identification Number
NCT04385836
Brief Title
Trial of Alpha One Antitrypsin Inhalation in Treating Patient With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
Official Title
Trial of Alpha One Antitrypsin Inhalation in Treating Patient With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2020 (Anticipated)
Primary Completion Date
September 1, 2020 (Anticipated)
Study Completion Date
September 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ministry of Health, Saudi Arabia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief 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 group of inhibitors, The best-studied serpins are antithrombin and alpha 1-antitrypsin
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronavirus
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
alpha one antitrypsin group
Arm Type
Active Comparator
Arm Description
- 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
Arm Title
placebo group
Arm Type
Placebo Comparator
Arm Description
we will give 8 ml of normal saline as nebulizer every 12 hours for 5 days
Intervention Type
Drug
Intervention Name(s)
alpha one antitrypsin inhalation
Intervention Description
- 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
Primary Outcome Measure Information:
Title
clinical improvement
Description
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
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.
10. Eligibility
Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
mohammed m othman
Phone
00966557881721
Email
Ossman231@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
mohammed m othman
Organizational Affiliation
MOH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ministry of Health
City
Mecca
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
mtair
Phone
0555509022
Email
research-makkah@moh.gov.sa
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Trial of Alpha One Antitrypsin Inhalation in Treating Patient With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
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