Coronavirus
Conditions
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
Interventions
DRUGalpha 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
Sponsors
Ministry of Health, Saudi Arabia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| clinical improvement | 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. | 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 |
Countries
Saudi Arabia
Contacts
Primary Contactmohammed m othman
Outcome results
None listed