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NCT04385836
Trial of Alpha One Antitrypsin Inhalation in Treating Patient With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
EARLY_PHASE1 trial testing alpha one antitrypsin inhalation in Coronavirus in 150 participants. Status unknown.
1 September 2020
Quick facts
| Lead sponsor | Ministry of Health, Saudi Arabia |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 150 |
| Start date | 1 June 2020 |
| Primary completion | 1 September 2020 |
| Estimated completion | 1 September 2020 |
| Sites | 1 location across Saudi Arabia |
Drugs / interventions tested
- alpha one antitrypsin inhalation — full drug profile →
Conditions studied
- Coronavirus — all drugs for Coronavirus →
Sponsor
Ministry of Health, Saudi Arabia
Who can join
18 and older, any sex, with Coronavirus. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Alpha-1 antitrypsin inhibits TMPRSS2 protease activity and SARS-CoV-2 infection.
Wettstein L, Weil T, Conzelmann C, Müller JA, et al · · 2021 · cited 114× · PMID 33741941 · DOI 10.1038/s41467-021-21972-0 -
A roadmap to pulmonary delivery strategies for the treatment of infectious lung diseases.
He S, Gui J, Xiong K, Chen M, et al · · 2022 · cited 91× · PMID 35241085 · DOI 10.1186/s12951-022-01307-x -
SARS-CoV-2 Antiviral Therapy.
Tao K, Tzou PL, Nouhin J, Bonilla H, et al · · 2021 · cited 80× · PMID 34319150 · DOI 10.1128/cmr.00109-21 -
Neutrophils in COVID-19: Not Innocent Bystanders.
McKenna E, Wubben R, Isaza-Correa JM, Melo AM, et al · · 2022 · cited 76× · PMID 35720378 · DOI 10.3389/fimmu.2022.864387 -
Aprotinin Inhibits SARS-CoV-2 Replication.
Bojkova D, Bechtel M, McLaughlin KM, McGreig JE, et al · · 2020 · cited 61× · PMID 33143316 · DOI 10.3390/cells9112377 -
A Review of Alpha-1 Antitrypsin Binding Partners for Immune Regulation and Potential Therapeutic Application.
O'Brien ME, Murray G, Gogoi D, Yusuf A, et al · · 2022 · cited 57× · PMID 35269582 · DOI 10.3390/ijms23052441 -
The Transmembrane Protease TMPRSS2 as a Therapeutic Target for COVID-19 Treatment.
Wettstein L, Kirchhoff F, Münch J. · · 2022 · cited 55× · PMID 35163273 · DOI 10.3390/ijms23031351 -
Atypical response to bacterial coinfection and persistent neutrophilic bronchoalveolar inflammation distinguish critical COVID-19 from influenza.
Cambier S, Metzemaekers M, de Carvalho AC, Nooyens A, et al · · 2022 · cited 50× · PMID 34793331 · DOI 10.1172/jci.insight.155055
Verify or expand the search:
- PubMed search for NCT04385836
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Ministry of Health, Saudi Arabia trials
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04385836 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Ministry of Health, Saudi Arabia
- Last refreshed: 13 May 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04385836.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing