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NCT04364763

A Study to Evaluate the Effect of RBT-9 on Progression of COVID-19 in High-Risk Individuals (The PREVENT Study)

Terminated Phase 2 Results posted Last updated 29 March 2023
What this trial tests

Phase 2 trial testing RBT-9 (90 mg) in COVID-19 in 42 participants. Terminated before completion.

Timeline
5 August 2020
Primary endpoint
2 September 2021
30 September 2021

Quick facts

Lead sponsorRenibus Therapeutics, Inc.
PhasePhase 2
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment42
Start date5 August 2020
Primary completion2 September 2021
Estimated completion30 September 2021
Sites5 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Renibus Therapeutics, Inc. — full company profile →

Who can join

18 and older, any sex, with COVID-19. 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.

Evaluate the Effect of RBT-9 Versus Placebo on Clinical Status of COVID-19 Patients as Measured Using the 8-point World Health Organization (WHO) Ordinal Clinical Scale Primary · baseline and 7 days, baseline and 28 days

Determining severity of COVID-19 in patients measured using the 8-point World Health Organization (WHO) Ordinal Clinical Scale which measures the clinical status of a subject at the first assessment of a given day with category 1, most favorable, and category 8, least favorable (1. Ambulatory, no limitation of activities; 2. Ambulatory, limitation of activities; 3. Hospitalized, no oxygen therapy; 4. Hospitalized, oxygen by mask or nasal prongs; 5. Hospitalized, non-invasive ventilation or high-flow oxygen; 6. Hospitalized, intubation and mechanical ventilation; 7. Hospitalized, ventilation pl

Day 7
GroupValue95% CI
RBT-9 (90 mg)-1.0-1.6 – -0.5
Placebo-0.0-0.8 – 0.8
Day 28
GroupValue95% CI
RBT-9 (90 mg)-1.2-1.8 – -0.7
Placebo-0.6-1.5 – 0.4

Adverse events — posted to ClinicalTrials.gov

Time frame: Subjects will receive a single dose of RBT-9 or placebo and study duration will be approximately 56 +/- 4 days per subject.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

RBT-9 (90 mg)
Serious: 3/28 (11%)
Deaths: 1/28
Placebo
Serious: 1/14 (7%)
Deaths: 2/14

Serious adverse events (4 terms)

ReactionSystemRBT-9 (90 mg)Placebo
Myocardial InfarctionCardiac disorders
Cerebral InfarctNervous system disorders
PneumoniaRespiratory, thoracic and mediastinal disorders
Lung massRespiratory, thoracic and mediastinal disorders
Other adverse events (7 terms — click to expand)

ReactionSystemRBT-9 (90 mg)Placebo
ErythemaSkin and subcutaneous tissue disorders
ParesthesiaNervous system disorders
RashSkin and subcutaneous tissue disorders
InsomniaPsychiatric disorders
OnychomycosisInfections and infestations
Tinea crurisInfections and infestations
TachycardiaCardiac disorders

Most-reported serious reactions: Myocardial Infarction, Cerebral Infarct, Pneumonia, Lung mass.

Data from ClinicalTrials.gov NCT04364763 adverse events section.

Sponsor's own description

The overall objective is to evaluate the efficacy, tolerability, and safety of a single dose of RBT-9 versus placebo in coronavirus disease 2019 (COVID-19) infection in non-critically ill adults who are at high risk of progression.

Publications & conference data

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

  1. Contribution of monocytes and macrophages to the local tissue inflammation and cytokine storm in COVID-19: Lessons from SARS and MERS, and potential therapeutic interventions.
    Jafarzadeh A, Chauhan P, Saha B, Jafarzadeh S, et al · · 2020 · cited 246× · PMID 32687918 · DOI 10.1016/j.lfs.2020.118102
  2. 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
  3. Primed for global coronavirus pandemic: Emerging research and clinical outcome.
    Ahamad S, Branch S, Harrelson S, Hussain MK, et al · · 2021 · cited 25× · PMID 33070079 · DOI 10.1016/j.ejmech.2020.112862
  4. Outcomes Evaluated in Controlled Clinical Trials on the Management of COVID-19: A Methodological Systematic Review.
    Mathioudakis AG, Fally M, Hashad R, Kouta A, et al · · 2020 · cited 14× · PMID 33333777 · DOI 10.3390/life10120350
  5. Novel corona virus (COVID-19); Global efforts and effective investigational medicines: A review.
    Goyal M, Tewatia N, Vashisht H, Jain R, et al · · 2021 · cited 12× · PMID 34119845 · DOI 10.1016/j.jiph.2021.04.011
  6. Different drug approaches to COVID-19 treatment worldwide: an update of new drugs and drugs repositioning to fight against the novel coronavirus.
    Oliver JC, Silva EN, Soares LM, Scodeler GC, et al · · 2022 · cited 10× · PMID 36578829 · DOI 10.1177/25151355221144845
  7. Oxidant- induced preconditioning: A pharmacologic approach for triggering renal 'self defense'.
    Zager RA. · · 2022 · cited 4× · PMID 36305701 · DOI 10.14814/phy2.15507

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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/NCT04364763.

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