Trial of Alpha One Antitrypsin Inhalation in Treating Patient With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)

Coronavirus Clinical Trial

Official title:

Trial of Alpha One Antitrypsin Inhalation in Treating Patient With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04385836
• Other study ID #: 4-0520- 076-K-02-H
• Status: Recruiting
• Phase: Early Phase 1
• 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
• 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

Related Conditions & MeSH terms

• Coronavirus
• Coronavirus Infections
• Severe Acute Respiratory Syndrome

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.