Trial of Alpha One Antitrypsin Inhalation in Treating Patient With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
1 other identifier
interventional
150
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started Jun 2020
Shorter than P25 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 10, 2020
CompletedFirst Posted
Study publicly available on registry
May 13, 2020
CompletedStudy Start
First participant enrolled
June 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2020
CompletedMay 13, 2020
May 1, 2020
3 months
May 10, 2020
May 12, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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
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.
Study Arms (2)
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
placebo group
PLACEBO COMPARATORwe will give 8 ml of normal saline as nebulizer every 12 hours for 5 days
Interventions
\- 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
Eligibility Criteria
You may qualify if:
- Positive RT-PCR) assay for SARS-CoV-2
- Age \>18 years
- Hospitalized
- Able to give informed consent
You may not qualify if:
- Known allergy to AAT
- imminent death within next 24 hours
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ministry of Health
Mecca, Saudi Arabia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
mohammed m othman
MOH
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- assistant consultant gastroenterology
Study Record Dates
First Submitted
May 10, 2020
First Posted
May 13, 2020
Study Start
June 1, 2020
Primary Completion
September 1, 2020
Study Completion
September 1, 2020
Last Updated
May 13, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will share