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

Ministry of Health, Saudi Arabia

Status and phase: Unknown; Early Phase 1

Conditions: Coronavirus

Treatments: Drug: alpha one antitrypsin inhalation

Study type: Interventional

Funder types: Other

Identifiers

NCT04385836

4-0520- 076-K-02-H

Details and patient eligibility

About

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

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 2 patient groups, including a placebo group

alpha one antitrypsin group

Active Comparator group

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

Treatment:

Drug: alpha one antitrypsin inhalation

placebo group

Placebo Comparator group

Description:

we will give 8 ml of normal saline as nebulizer every 12 hours for 5 days

Treatment:

Drug: alpha one antitrypsin inhalation