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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04385836
Other study ID # 4-0520- 076-K-02-H
Secondary ID
Status Recruiting
Phase Early Phase 1
First received
Last updated
Start date June 1, 2020
Est. completion date September 1, 2020

Study information

Verified date May 2020
Source Ministry of Health, Saudi Arabia
Contact mohammed m othman
Phone 00966557881721
Email Ossman231@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 group of inhibitors, The best-studied serpins are antithrombin and alpha 1-antitrypsin


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date September 1, 2020
Est. primary completion date September 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Positive RT-PCR) assay for SARS-CoV-2

2. Age >18 years

3. Hospitalized

4. Able to give informed consent

Exclusion Criteria:

1. Known allergy to AAT

2. imminent death within next 24 hours

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
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

Locations

Country Name City State
Saudi Arabia Ministry of Health Mecca

Sponsors (1)

Lead Sponsor Collaborator
Ministry of Health, Saudi Arabia

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
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