Kim: A Double-blind, Multi-center, Multi-regional, Randomized Controlled, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of CKD-314 in Hospitalized Adult Patients Diagnosed With COVID-19 [Nafamostat]

Estimated 586 patient nafamostat late treatment RCT with results not reported over 4 years after estimated completion.

4 nafamostat RCTs have results missing long after expected1-4
The trials report a total of 742 patients, with 2 trials having actual enrollment of 72, and the remainder estimated.

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Study covers TMPRSS2 inhibitors and nafamostat.

1. Seydi et al., Multicentre, Open Label, Randomised, Adaptative Clinical Trial of Efficacy and Safety of Treatment Regimens in Adult COVID-19 Patients in Senegal, NCT04390594, clinicaltrials.gov/study/NCT04390594clinicaltrials.gov.

2. Kim et al., A Double-blind, Multi-center, Multi-regional, Randomized Controlled, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of CKD-314 in Hospitalized Adult Patients Diagnosed With COVID-19, NCT04871646, clinicaltrials.gov/study/NCT04871646clinicaltrials.gov.

3. Bae et al., Treatment Effect of Nafamostat Mesylate in Patients With COVID-19 Pneumonia: Open Labelled Randomized Controlled Clinical Trial, NCT04418128, clinicaltrials.gov/study/NCT04418128clinicaltrials.gov.

4. Kim (B) et al., Open-label, Multi-center, Randomized Controlled, Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of CKD-314 in Hospitalized Adult Patients Diagnosed With COVID-19, NCT04628143, clinicaltrials.gov/study/NCT04628143clinicaltrials.gov.

Kim et al., 1 Aug 2022, Double Blind Randomized Controlled Trial, placebo-controlled, South Korea, trial NCT04871646 (history). Contact: dasom@ckdpharm.com.

Late treatment
is less effective

Most accessed treatments

Antiviral effects

Vitamins & Minerals

Host endosomal entry / trafficking

Dual-action mAbs

RdRp

Nasal & Oral Sprays / Rinses

Analgesics

Antiandrogens

Host targets and pathways

Inflammatory and immune modulation

Mpro (Gen 1)

Oxidative stress and cytoprotection

Lifestyles

TMPRSS2

Spike neutralization

Replication inhibition (target unresolved)

COVID-19 mAbs

Pleiotropic modulation

Attachment / entry inhibition

Mpro (Gen 2)

H1RAs

Nutrients and microbiome support

Host mAbs

IL-6 / IL-6R blockade

Physical and extracorporeal interventions

Natural products and extracts

Symptom management

Unconfirmed antiviral rationale

Lifestyle, behaviors, and exposure prevention

Other complication management

Mpro / 3CLpro

Host pyrimidine synthesis

Direct viral inactivation

Endothelial / vascular protection

Direct respiratory tract treatments

Other antibodies, proteins, peptides, cells, and RNA therapies

Secondary infection and coinfection management

A Double-blind, Multi-center, Multi-regional, Randomized Controlled, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of CKD-314 in Hospitalized Adult Patients Diagnosed With COVID-19