Who is sponsoring NCT05054114?

NCT05054114 is sponsored by SPP Pharmaclon Ltd..

What drugs are being tested in NCT05054114?

Interventions in NCT05054114: Interferon gamma human recombinant (IFN-G).

What condition does NCT05054114 study?

NCT05054114 studies COVID-19 Respiratory Infection, Acute Respiratory Disease.

Is NCT05054114 still recruiting?

NCT05054114 is currently completed. Last updated 9 August 2024.

Are results published for NCT05054114?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-08-09 · How we verify

NCT05054114

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

Study of the Use of Nasal IFN-γ in Patients for the Prevention of Acute Respiratory Viral Infections, Icluding COVID-19

Completed NA Results posted Last updated 9 August 2024

What this trial tests

NA trial testing Interferon gamma human recombinant (IFN-G) in COVID-19 Respiratory Infection in 630 participants. Completed in 2 September 2021.

Timeline

21 December 2020

Primary endpoint
25 May 2021

2 September 2021

Quick facts

Lead sponsor	SPP Pharmaclon Ltd.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	630
Start date	21 December 2020
Primary completion	25 May 2021
Estimated completion	2 September 2021
Sites	1 location across Russia

Drugs / interventions tested

Interferon gamma human recombinant (IFN-G) — full drug profile →

Conditions studied

COVID-19 Respiratory Infection — all drugs for COVID-19 Respiratory Infection →
Acute Respiratory Disease — all drugs for Acute Respiratory Disease →

Sponsor

SPP Pharmaclon Ltd. — full company profile →

Who can join

18 and older, any sex, with COVID-19 Respiratory Infection or Acute Respiratory Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

The Proportion of Patients With Acute Respiratory Viral Infections, Including COVID-19, at the End of the Prophylactic Period Primary · 28 days

The proportion of patients with acute respiratory viral infections, including COVID-19, assessed at visit 2 (at the end of the prophylaxis course and before the start of the follow-up period)

Group	Value	95% CI
Drug: Interferon Gamma	3
Control: No Intervention	13

The Proportion of Patients With Confirmed COVID-19 at the End of the Prophylactic Period Secondary · 28 days

The proportion of patients with COVID-19, assessed at visit 2 (at the end of the prophylaxis course and before the start of the follow-up period)

Group	Value	95% CI
Drug: Interferon Gamma	0
Control: No Intervention	0

The Proportion of Patients With Acute Respiratory Viral Infections, Including COVID-19, at the End of the Follow-up Period Secondary · 2 months

The proportion of patients with acute respiratory viral infections, including COVID-19, assessed at visit 3 (at the end of the study)

Group	Value	95% CI
Drug: Interferon Gamma	6
Control: No Intervention	25

Proportion of Patients With Confirmed COVID-19 at the End of the Follow-up Period Secondary · 2 months

The proportion of patients with COVID-19, assessed at visit 3 (at the end of the study)

Group	Value	95% CI
Drug: Interferon Gamma	0
Control: No Intervention	2

Number of Participants With a Complicated Course of Infection Secondary · 2 months

The rate of complicated courses of infection among cases

Group	Value	95% CI
Drug: Interferon Gamma	0
Control: No Intervention	0

The Proportion of Participants With Each Score of the WHO Clinical Improvement Scale Secondary · 28 days

The proportion of participants with each score (0-8) on the WHO Clinical Improvement Scale from 0 points - not infected, no manifestations or virological signs of infection, up to 8 points - died, death

0 points on the WHO scale

Group	Value	95% CI
Drug: Interferon Gamma	0
Control: No Intervention	0

1 points on the WHO scale

Group	Value	95% CI
Drug: Interferon Gamma	3
Control: No Intervention	13

2 points on the WHO scale

Group	Value	95% CI
Drug: Interferon Gamma	0
Control: No Intervention	0

3 points on the WHO scale

Group	Value	95% CI
Drug: Interferon Gamma	0
Control: No Intervention	0

4 points on the WHO scale

Group	Value	95% CI
Drug: Interferon Gamma	0
Control: No Intervention	0

5 points on the WHO scale

Group	Value	95% CI
Drug: Interferon Gamma	0
Control: No Intervention	0

6 points on the WHO scale

Group	Value	95% CI
Drug: Interferon Gamma	0
Control: No Intervention	0

7 points on the WHO scale

Group	Value	95% CI
Drug: Interferon Gamma	0
Control: No Intervention	0

The Proportion of Participants With Each Score of the WHO Clinical Improvement Scale Secondary · 2 months

0 points on the WHO scale

Group	Value	95% CI
Drug: Interferon Gamma	0
Control: No Intervention	0

1 points on the WHO scale

Group	Value	95% CI
Drug: Interferon Gamma	6
Control: No Intervention	25

2 points on the WHO scale

Group	Value	95% CI
Drug: Interferon Gamma	0
Control: No Intervention	1

3 points on the WHO scale

Group	Value	95% CI
Drug: Interferon Gamma	0
Control: No Intervention	0

4 points on the WHO scale

Group	Value	95% CI
Drug: Interferon Gamma	0
Control: No Intervention	0

5 points on the WHO scale

Group	Value	95% CI
Drug: Interferon Gamma	0
Control: No Intervention	0

6 points on the WHO scale

Group	Value	95% CI
Drug: Interferon Gamma	0
Control: No Intervention	0

7 points on the WHO scale

Group	Value	95% CI
Drug: Interferon Gamma	0
Control: No Intervention	0

The Duration of Symptoms in Participants With Acute Respiratory Viral Infections, Including COVID-19 Secondary · 2 months

The duration of symptoms in participants with acute respiratory viral infections, including COVID-19, assessed at the end of the study

Group	Value	95% CI
Drug: Interferon Gamma	4.17	2.00 – 8.00
Control: No Intervention	6.76	1.00 – 24.00

The Duration of Symptoms in Participants With Acute Respiratory Viral Infections, Including COVID-19 Secondary · 28 days

The duration of symptoms in participants with acute respiratory viral infections, including COVID-19, assessed at the end of prevention course

Group	Value	95% CI
Drug: Interferon Gamma	5.33	2.00 – 8.00
Control: No Intervention	4.15	1.00 – 8.00

Adverse events — posted to ClinicalTrials.gov

Time frame: Safety assessment was carried out throughout the observation period, starting from the inclusion of the participant in the study - within 2 months.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Drug: Interferon Gamma

Serious: 0/315 (0%)

Deaths: 0/315

Control: No Intervention

Serious: 0/315 (0%)

Deaths: 0/315

Other adverse events (13 terms — click to expand)

Reaction	System	Drug: Interferon Gamma	Control: No Intervention
Headache	Nervous system disorders	—	—
Increase in blood pressure	Vascular disorders	—	—
Abdominal pain	Gastrointestinal disorders	—	—
Lower abdominal pain	Reproductive system and breast disorders	—	—
Rashes on the nasal mucosa (herpetic)	Infections and infestations	—	—
Dizziness	Nervous system disorders	—	—
Diarrhea	Gastrointestinal disorders	—	—
Joint pain	Injury, poisoning and procedural complications	—	—
Skin hardening	Infections and infestations	—	—
Toothache	Gastrointestinal disorders	—	—
Frequent urination	Renal and urinary disorders	—	—
Increasing PSA levels	Reproductive system and breast disorders	—	—
Pain when urinating (exacerbation of chronic prostatitis)	Reproductive system and breast disorders	—	—

Data from ClinicalTrials.gov NCT05054114 adverse events section.

Sponsor's own description

It is known that the pretreatment with exogenous interferon blocks SARS-CoV-2 infection, but intervention is much more effective if administered prior to infection. In this study the primary aim is to investigate 28-day regime of nasal interferon gama use in healthy participants for COVID-19 and other respiratory infections prevention.

Publications & conference data

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

Molecular and neuroimmune pharmacology of S1P receptor modulators and other disease-modifying therapies for multiple sclerosis.
Kihara Y, Chun J. · · 2023 · cited 13× · PMID 37149155 · DOI 10.1016/j.pharmthera.2023.108432
Type-I interferons in the immunopathogenesis and treatment of Coronavirus disease 2019.
Khorramdelazad H, Kazemi MH, Azimi M, Aghamajidi A, et al · · 2022 · cited 11× · PMID 35618037 · DOI 10.1016/j.ejphar.2022.175051
Interactions between COVID-19 and Lung Cancer: Lessons Learned during the Pandemic.
Bian DJH, Sabri S, Abdulkarim BS. · · 2022 · cited 9× · PMID 35892857 · DOI 10.3390/cancers14153598
Yin and yang of interferons: lessons from the coronavirus disease 2019 (COVID-19) pandemic.
Svensson Akusjärvi S, Zanoni I. · · 2024 · cited 5× · PMID 38776716 · DOI 10.1016/j.coi.2024.102423
The immunology and immunotherapy for COVID-19.
Liu Y, Zhou X, Liu X, Jiang X. · · 2021 · cited 3× · PMID 34915958 · DOI 10.1017/erm.2021.30
IL-10 suppresses T cell expansion while promoting tissue-resident memory cell formation during SARS-CoV-2 infection in rhesus macaques
Nelson CE, Foreman TW, Kauffman KD, Sakai S, et al · · 2022 · DOI 10.1101/2022.09.13.507852

Verify or expand the search:

Other trials of Interferon gamma human recombinant (IFN-G)

Trials testing the same drug.

NCT05386446 — Study of the Use of the Ingaron in Volunteers for the Prevention of COVID-19 · completed
NCT05156541 — Study of the Efficacy and Safety of the Drug Ingaron (Interferon-gamma) in the Treatment of Anogenital Warts · Phase 3 · completed

Other recruiting trials for COVID-19 Respiratory Infection

Currently open trials in the same condition.

NCT06950177 — Pancoronavirus Vaccine Study in Healthy Adults · Phase 1 · active not recruiting
NCT06402318 — Passive Detection- SARS-CoV-2 (COVID-19) A&M Breathalyzer (PROTECT Kiosk) for Operational Medicine · recruiting
NCT05765396 — SARS-CoV-2/COVID-19 Study of Next Generation Non-Invasive Passive Detection Technologies · active not recruiting
NCT05689034 — Multicenter Randomized Double-blind Placebo-controlled Study to Investigate Azvudine in Symptomatic Adults With COVID-19 · Phase 2, PHASE3 · recruiting
NCT05562505 — Trial of Venovenous ECMO to De-Sedate, Extubate and Mobilise in Hypoxic Respiratory Failure · NA · recruiting

Other SPP Pharmaclon Ltd. trials

Trials by the same sponsor.

NCT06118619 — A Multicenter Clinical Trial of Ingaron in Pulmonary Tuberculosis · unknown
NCT05359315 — Study on the Use of Interferon Gamma (Ingaron) Injections in Patients With Drug-resistant Pulmonary Tuberculosis · unknown
NCT05386446 — Study of the Use of the Ingaron in Volunteers for the Prevention of COVID-19 · completed
NCT05386459 — Study of the Use of the Drug Ingaron in Patients With COVID-19 · completed
NCT05395702 — Study of Ingaron's Effect on Efficacy and Resistance to Antibiotics in Community-acquired Pneumonia · 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 NCT05054114 (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 SPP Pharmaclon Ltd.
Last refreshed: 9 August 2024

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/NCT05054114.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing