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

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: September 1, 2020

Interventions

  • 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

Arms, Groups and Cohorts

  • Active Comparator: alpha one antitrypsin group
    • – 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 Comparator: placebo group
    • we will give 8 ml of normal saline as nebulizer every 12 hours for 5 days

Clinical Trial Outcome Measures

Primary Measures

  • clinical improvement
    • Time Frame: 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ministry of Health, Saudi Arabia
  • Provider of Information About this Clinical Study
    • Principal Investigator: mohamed mahmoud mohamed othman, assistant consultant gastroenterology – Ministry of Health, Saudi Arabia
  • Overall Official(s)
    • mohammed m othman, Principal Investigator, MOH
  • Overall Contact(s)
    • mohammed m othman, 00966557881721, Ossman231@yahoo.com

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