NCT04424134 (BISCUIT) is a Phase 3 clinical trial of Bromhexine and Spironolactone in COVID 19, sponsored by Lomonosov Moscow State University Medical Research and Educational Center.

What drugs are being tested in NCT04424134?

Interventions in NCT04424134: Bromhexine and Spironolactone, Base therapy.

Is NCT04424134 still recruiting?

NCT04424134 is currently status unknown. Last updated 9 June 2020.

Last reviewed 2020-06-09 · How we verify

NCT04424134: BISCUIT

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

BromhexIne And Spironolactone For CoronаVirUs Infection Requiring HospiTalization

Status unknown Phase 3 Last updated 9 June 2020

What this trial tests

Phase 3 trial testing Bromhexine and Spironolactone in COVID 19 in 80 participants. Status unknown.

Timeline

16 May 2020

Primary endpoint
18 July 2020

23 August 2020

Quick facts

Lead sponsor	Lomonosov Moscow State University Medical Research and Educational Center
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	80
Start date	16 May 2020
Primary completion	18 July 2020
Estimated completion	23 August 2020
Sites	1 location across Russia

Drugs / interventions tested

Bromhexine and Spironolactone — full drug profile →
Base therapy — full drug profile →

Conditions studied

COVID 19 — all drugs for COVID 19 →

Sponsor

Lomonosov Moscow State University Medical Research and Educational Center

Who can join

18 and older, any sex, with COVID 19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Patients with mild and severe COVID 19 will be randomized 1:1 into two groups: experimental, which will get bromhexine and spironolactone, and control. Patients will get investigated therapy for ten days. Change in clinical assessment score COVID 19 (CAS COVID 19) between baseline and 12th day will be evaluated as a primary endpoint. Forty-five-day risk of death or mechanical ventilation will also be assessed.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

An update on drugs with therapeutic potential for SARS-CoV-2 (COVID-19) treatment.
Drożdżal S, Rosik J, Lechowicz K, Machaj F, et al · · 2021 · cited 186× · PMID 34991982 · DOI 10.1016/j.drup.2021.100794
Targeting transcriptional regulation of SARS-CoV-2 entry factors <i>ACE2</i> and <i>TMPRSS2</i>.
Qiao Y, Wang XM, Mannan R, Pitchiaya S, et al · · 2021 · cited 155× · PMID 33310900 · DOI 10.1073/pnas.2021450118
Races of small molecule clinical trials for the treatment of COVID-19: An up-to-date comprehensive review.
Hu S, Jiang S, Qi X, Bai R, et al · · 2022 · cited 68× · PMID 34762760 · DOI 10.1002/ddr.21895
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
The intersection of COVID-19 and cancer: signaling pathways and treatment implications.
Zong Z, Wei Y, Ren J, Zhang L, et al · · 2021 · cited 54× · PMID 34001144 · DOI 10.1186/s12943-021-01363-1
Potential Anti-COVID-19 Therapeutics that Block the Early Stage of the Viral Life Cycle: Structures, Mechanisms, and Clinical Trials.
Al-Horani RA, Kar S, Aliter KF. · · 2020 · cited 35× · PMID 32718020 · DOI 10.3390/ijms21155224
ACE2 as a Therapeutic Target for COVID-19; its Role in Infectious Processes and Regulation by Modulators of the RAAS System.
Michaud V, Deodhar M, Arwood M, Al Rihani SB, et al · · 2020 · cited 29× · PMID 32635289 · DOI 10.3390/jcm9072096
Beneficial Effects of Mineralocorticoid Receptor Pathway Blockade against Endothelial Inflammation Induced by SARS-CoV-2 Spike Protein.
Jover E, Matilla L, Garaikoetxea M, Fernández-Celis A, et al · · 2021 · cited 21× · PMID 34204890 · DOI 10.3390/biomedicines9060639

Verify or expand the search:

Other recruiting trials for COVID 19

Currently open trials in the same condition.

NCT06871293 — Evaluating the Impact of a Functional and Cognitive Strategy in Patients With Long Covid-19 · NA · recruiting
NCT06599658 — COVID-19 Booster and IIV Schedule in Immunocompromised Hosts · Phase 2 · recruiting
NCT04359836 — A Study to Explore the Role of Gut Flora in COVID-19 Infection · recruiting
NCT04522076 — Prospective Hospital Registry of Patients With Suspected or Confirmed Coronavirus Infection (COVID-19) and Community-acq · active not recruiting
NCT06702540 — Bio-reconfigurable Electronic Platform for Multiplex Detection of Viral Respiratory Pathogens · active not recruiting

Other Lomonosov Moscow State University Medical Research and Educational Center trials

Trials by the same sponsor.

NCT04403243 — COLchicine Versus Ruxolitinib and Secukinumab in Open-label Prospective Randomized Trial in Patients With COVID-19 · Phase 2 · completed
NCT03726905 — Complex Exercises of the Respiratory Muscles Plus Aerobic Training vs. Aerobic Training in Patients With СHF · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04424134 (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 Lomonosov Moscow State University Medical Research and Educational Center
Last refreshed: 9 June 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/NCT04424134.

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