NCT04254874

A Prospective/Retrospective,Randomized Controlled Clinical Study of Interferon Atomization in the 2019-nCoV Pneumonia

Status unknown Phase 4 Last updated 17 March 2020

What this trial tests

Phase 4 trial testing Abidol hydrochloride in 2019-nCoV in 100 participants. Status unknown.

Timeline

1 February 2020

Primary endpoint
1 June 2020

1 July 2020

Quick facts

Lead sponsor	Tongji Hospital
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	100
Start date	1 February 2020
Primary completion	1 June 2020
Estimated completion	1 July 2020
Sites	1 location across China

Drugs / interventions tested

• Abidol hydrochloride — full drug profile →
• Abidol Hydrochloride combined with Interferon atomization — full drug profile →

Conditions studied

• 2019-nCoV — all drugs for 2019-nCoV →

Sponsor

Tongji Hospital

Who can join

18 and older, any sex, with 2019-nCoV. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

At present, there is no specific and effective antiviral therapy.In this study, an open, prospective/retrospective, randomized controlled cohort study was designed to compare the efficacy of two therapeutic schemes(abidol hydrochloride,abidol hydrochloride combined with interferon atomization)in the treatment of 2019-nCoV viral pneumonia, so as to provide reliable evidence-based medicine for the treatment of viral pneumonia caused by 2019-nCoV.

Publications & conference data

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

1. SARS-CoV-2: an Emerging Coronavirus that Causes a Global Threat.
   Zheng J. · · 2020 · cited 528× · PMID 32226285 · DOI 10.7150/ijbs.45053
2. Should we stimulate or suppress immune responses in COVID-19? Cytokine and anti-cytokine interventions.
   Jamilloux Y, Henry T, Belot A, Viel S, et al · · 2020 · cited 486× · PMID 32376392 · DOI 10.1016/j.autrev.2020.102567
3. The epidemiology, diagnosis and treatment of COVID-19.
   Zhai P, Ding Y, Wu X, Long J, et al · · 2020 · cited 461× · PMID 32234468 · DOI 10.1016/j.ijantimicag.2020.105955
4. COVID-19: Transmission, prevention, and potential therapeutic opportunities.
   Lotfi M, Hamblin MR, Rezaei N. · · 2020 · cited 447× · PMID 32474009 · DOI 10.1016/j.cca.2020.05.044
5. An overview of COVID-19.
   Shi Y, Wang G, Cai XP, Deng JW, et al · · 2020 · cited 260× · PMID 32425000 · DOI 10.1631/jzus.b2000083
6. Ongoing Clinical Trials for the Management of the COVID-19 Pandemic.
   Lythgoe MP, Middleton P. · · 2020 · cited 247× · PMID 32291112 · DOI 10.1016/j.tips.2020.03.006
7. Immune-mediated approaches against COVID-19.
   Florindo HF, Kleiner R, Vaskovich-Koubi D, Acúrcio RC, et al · · 2020 · cited 219× · PMID 32661375 · DOI 10.1038/s41565-020-0732-3
8. 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