NCT05187793: RESET

A Multicenter, Open-label, Randomized Study of the Efficacy and Safety of Artlegia (INN: Olokizumab) New Dosing Regimen in Patients With Coronavirus Infection (COVID-19) With Signs of Hyperinflammation

Status unknown Phase 3 Last updated 9 February 2023

What this trial tests

Phase 3 trial testing Olokizumab in COVID-19 in 198 participants. Status unknown.

Timeline

8 July 2021

Primary endpoint
31 October 2022

1 April 2023

Quick facts

Lead sponsor	R-Pharm
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	198
Start date	8 July 2021
Primary completion	31 October 2022
Estimated completion	1 April 2023
Sites	5 locations across Russia

Drugs / interventions tested

• Olokizumab — full drug profile →
• Standard therapy — full drug profile →

Conditions studied

• COVID-19 — all drugs for COVID-19 →

Sponsor

R-Pharm — full company profile →

Who can join

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

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Clinical recovery rate at day 7
  Time frame: Up to day 7
  Clinical recovery defined as score of 3 or less on a 10-point ordinal scale of clinical improvement. (From 0 "Healthy - no clinical manifestations, no viral RNA detected" to 10 "Death".) 7 days are counted from the day of the first administration / intake of study therapy / comparison therapy, depending on study group. Criteria for transition from category "4" to category "3" (criteria for poten

Sponsor's own description

The primary objective of the study is to evaluate the efficacy and safety of Artlegia (INN: olokizumab) new dosing regimen in patients with moderate coronavirus infection (COVID-19) with signs of hyperinflammation.

This study is a multicentre, open-label, randomized, comparative, parallel group, active-controlled clinical trial.

Publications & conference data

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

1. Development of therapeutic antibodies for the treatment of diseases.
   Wang Z, Wang G, Lu H, Li H, et al · · 2022 · cited 69× · PMID 36418786 · DOI 10.1186/s43556-022-00100-4
2. Cell deaths: Involvement in the pathogenesis and intervention therapy of COVID-19.
   Li X, Zhang Z, Wang Z, Gutiérrez-Castrellón P, et al · · 2022 · cited 58× · PMID 35697684 · DOI 10.1038/s41392-022-01043-6
3. Alternative Routes of Administration for Therapeutic Antibodies-State of the Art.
   Pitiot A, Heuzé-Vourc'h N, Sécher T. · · 2022 · cited 45× · PMID 36134952 · DOI 10.3390/antib11030056
4. Interleukin-6 blocking agents for treating COVID-19: a living systematic review.
   Ghosn L, Assi R, Evrenoglou T, Buckley BS, et al · · 2023 · cited 26× · PMID 37260086 · DOI 10.1002/14651858.cd013881.pub2
5. Therapeutic implications of current Janus kinase inhibitors as anti-COVID agents: A review.
   Jain NK, Tailang M, Jain HK, Chandrasekaran B, et al · · 2023 · cited 24× · PMID 37021053 · DOI 10.3389/fphar.2023.1135145
6. Recent clinical findings on the role of kinase inhibitors in COVID-19 management.
   Malekinejad Z, Baghbanzadeh A, Nakhlband A, Baradaran B, et al · · 2022 · cited 15× · PMID 35841979 · DOI 10.1016/j.lfs.2022.120809
7. Targeting Human Proteins for Antiviral Drug Discovery and Repurposing Efforts: A Focus on Protein Kinases.
   Hajjo R, Sabbah DA, Abusara OH, Kharmah R, et al · · 2023 · cited 12× · PMID 36851782 · DOI 10.3390/v15020568
8. Differential Roles of Interleukin-6 in Severe Acute Respiratory Syndrome-Coronavirus-2 Infection and Cardiometabolic Diseases.
   Ren J, Wang XQ, Nakao T, Libby P, et al · · 2023 · PMID 38152628 · DOI 10.1097/cd9.0000000000000096