Evaluating Emetine for Viral Outbreaks (EVOLVE)

NCT05889793 | Terminated Phase 2 FDA Drug

• 1 other identifier: IRB00283778
• Study Type: interventional
• Target: 4
• Locations: 2 countries
• Sites: 2

Brief Summary

The goal of this clinical trial (phase 2/phase 3) is to evaluate the efficacy and safety of emetine administered orally for symptomatic Covid-19 patients in patients ages 30 years and above. Participants will be asked to:

• Take Emetine 6mg orally for 10 consecutive days
• Be monitored by healthcare staff or self-monitor for daily vital signs and symptoms
• Undergo blood draws Researchers will compare the control group given placebo medicine to assess if emetine improved the symptoms of Covid-19.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (4)

• Evaluate effectiveness of emetine in symptomatic Covid-19 patients

  Effectiveness of emetine will be assessed by a 1) composite outcome of Hospitalization, ICU admission, mechanical ventilation, death

  After medication administration up to 30 days

• Evaluate effectiveness of emetine in symptomatic Covid-19 patients

  Recovery without symptoms (≥3 days without symptoms) will be assessed.

  After medication administration up to 30 days

• Evaluate safety of emetine in symptomatic Covid-19 patients

  All serious adverse events (SAEs), adverse events (AEs) will be documented and described using descriptive statistics. Adverse events will be per the Medical Dictionary for Regulatory Activities (MedDRA) and categorized by system organ class, accompanied by duration (in days), and start and stop dates.

  Duration of the intervention and for up to 30 days post intervention

• Evaluate safety of emetine in symptomatic Covid-19 patients

  Record rates of drug discontinuation.

  Duration of intervention up to 10 days

Secondary Outcomes (7)

• Virologic conversion as assessed by SARS-CoV-2 real time polymerase chain reaction (RT-PCR)

  Day 0 and then at days 3, 5 and 10

• Anti-inflammatory effect of emetine

  Days 0 (baseline), 3 and 7 for up to 10 days after intervention

• Anti-inflammatory effect of emetine

  Days 0 (baseline), 3 and 7 for up to 10 days after intervention

• Anti-inflammatory effect of emetine

  Days 0 (baseline), 3 and 7 for up to 10 days after intervention

• Anti-inflammatory effect of emetine

  Days 0 (baseline) 3 and 7 for up to 10 days after intervention.

Other Outcomes (1)

• Determine longer term impact of Covid-19 as assessed by the Health-related quality of life assessment (HR-QOL-14)

  Days 30, 90 and 180 after medication administration up to day 180.

Study Arms (2)

Emetine

ACTIVE COMPARATOR

Participant takes Emetine 6mg for 10 consecutive days

Drug: Emetine Hydrochloride

Placebo

PLACEBO COMPARATOR

Participant takes a placebo for 10 consecutive days

Drug: Placebo

Interventions

Emetine Hydrochloride DRUG

To administer Emetine Hydrochloride 6mg orally for 10 consecutive days to evaluate the efficacy and safety of emetine for symptomatic Covid-19 patients.

Emetine

Placebo DRUG

Participant takes a placebo for 10 consecutive days.

Placebo

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older at time of randomization
• RT-PCR positive for SARS-CoV-2 infection within ≤ 10 days of the screening visit.
• In addition to confirmed RT-PCR, symptomatic Covid-19 patients with at least two or more symptoms within 7 days of the screening visit: Cough, shortness of breath, fever/chills, sore throat, nausea, vomiting, diarrhea, fatigue, body aches, headache
• Ability to give informed consent (administered in local language)

You may not qualify if:

• Asymptomatic Covid-19 patients
• Pregnant or breastfeeding woman
• Current or recent use of the study drug
• Known allergy to study drug
• Current or planned participation in another interventional trial in next 10 days.
• Critical Covid-19 patients (ARDS) at the time of screening.
• Patients needing intubation, mechanical ventilation, or ICU care at screening
• Patients with prior cardiac disease including cardiac dysrhythmias, heart failure, ischemic heart disease or cardiomyopathies.

Sponsors & Collaborators

• Bharatpur Hospital Chitwan: collaborator
• Stony Brook University: collaborator
• Rutgers University: collaborator
• Johns Hopkins University: lead
• Nepal Health Research Council: collaborator

Study Sites (2)

Johns Hopkins University, Division of Infectious Diseases

Baltimore, Maryland, 21231, United States

Location

Bharatpur Hospital

Bharatpur, Chitwan, 00000, Nepal

Location

Related Publications (8)

• VEDDER, E.B. Origin and present status of the emetine treatment of amebic dysentery. JAMA. 1914;LXII (7):501-6. doi:10.1001/jama.1914.02560320001001.

  BACKGROUND

• Bleasel MD, Peterson GM. Emetine Is Not Ipecac: Considerations for Its Use as Treatment for SARS-CoV2. Pharmaceuticals (Basel). 2020 Nov 27;13(12):428. doi: 10.3390/ph13120428.

  PMID: 33261173 BACKGROUND

• Bleasel MD, Peterson GM. Emetine, Ipecac, Ipecac Alkaloids and Analogues as Potential Antiviral Agents for Coronaviruses. Pharmaceuticals (Basel). 2020 Mar 21;13(3):51. doi: 10.3390/ph13030051.

  PMID: 32245264 BACKGROUND

• Jan JT, Cheng TR, Juang YP, Ma HH, Wu YT, Yang WB, Cheng CW, Chen X, Chou TH, Shie JJ, Cheng WC, Chein RJ, Mao SS, Liang PH, Ma C, Hung SC, Wong CH. Identification of existing pharmaceuticals and herbal medicines as inhibitors of SARS-CoV-2 infection. Proc Natl Acad Sci U S A. 2021 Feb 2;118(5):e2021579118. doi: 10.1073/pnas.2021579118.

  PMID: 33452205 BACKGROUND

• Dyall J, Coleman CM, Hart BJ, Venkataraman T, Holbrook MR, Kindrachuk J, Johnson RF, Olinger GG Jr, Jahrling PB, Laidlaw M, Johansen LM, Lear-Rooney CM, Glass PJ, Hensley LE, Frieman MB. Repurposing of clinically developed drugs for treatment of Middle East respiratory syndrome coronavirus infection. Antimicrob Agents Chemother. 2014 Aug;58(8):4885-93. doi: 10.1128/AAC.03036-14. Epub 2014 May 19.

  PMID: 24841273 BACKGROUND

• Liu Q, Xia S, Sun Z, Wang Q, Du L, Lu L, Jiang S. Testing of Middle East respiratory syndrome coronavirus replication inhibitors for the ability to block viral entry. Antimicrob Agents Chemother. 2015 Jan;59(1):742-4. doi: 10.1128/AAC.03977-14. Epub 2014 Oct 20. No abstract available.

  PMID: 25331705 BACKGROUND

• Yang S, Xu M, Lee EM, Gorshkov K, Shiryaev SA, He S, Sun W, Cheng YS, Hu X, Tharappel AM, Lu B, Pinto A, Farhy C, Huang CT, Zhang Z, Zhu W, Wu Y, Zhou Y, Song G, Zhu H, Shamim K, Martinez-Romero C, Garcia-Sastre A, Preston RA, Jayaweera DT, Huang R, Huang W, Xia M, Simeonov A, Ming G, Qiu X, Terskikh AV, Tang H, Song H, Zheng W. Emetine inhibits Zika and Ebola virus infections through two molecular mechanisms: inhibiting viral replication and decreasing viral entry. Cell Discov. 2018 Jun 5;4:31. doi: 10.1038/s41421-018-0034-1. eCollection 2018.

  PMID: 29872540 BACKGROUND

• Mukhopadhyay R, Roy S, Venkatadri R, Su YP, Ye W, Barnaeva E, Mathews Griner L, Southall N, Hu X, Wang AQ, Xu X, Dulcey AE, Marugan JJ, Ferrer M, Arav-Boger R. Efficacy and Mechanism of Action of Low Dose Emetine against Human Cytomegalovirus. PLoS Pathog. 2016 Jun 23;12(6):e1005717. doi: 10.1371/journal.ppat.1005717. eCollection 2016 Jun.

  PMID: 27336364 BACKGROUND

MeSH Terms

Conditions

COVID-19

Interventions

Emetine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Kunchok Dorjee, MBBS, PhD, MPH

  Johns Hopkins School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double-blinded trial
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double-blinded randomized controlled clinical trial (RCT) with placebo and intervention group

Study Record Dates

• First Submitted: May 23, 2023
• First Posted: June 5, 2023
• Study Start: May 15, 2024
• Primary Completion: December 15, 2025
• Study Completion: December 15, 2025
• Last Updated: January 23, 2026

Record last verified: 2026-01

Locations

NE (1); US (1)