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Safety of oral molnupiravir administration for hospitalized elderly COVID-19 patients aged 80 years old or older

Early treatment with molnupiravir in the elderly at risk for Covid-19

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN79981540
Enrollment
29
Registered
2022-07-15
Start date
2022-01-17
Completion date
Unknown
Last updated
2022-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hospitalized elderly with at least one risk factor for Covid-19 disease Infections and Infestations

Interventions

We retrospectively evaluated the efficacy and safety of treatment with molnupiravir, which we started oral administration within 24 hours after the onset of signs or symptoms in hospitalized elderly w

Sponsors

Fukushima Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Over 80 years of age 2. At least one risk factor of: age >60 years, active cancer, chronic kidney disease, chronic obstructive pulmonary disease, obesity defined by a body-mass index (the weight in kilograms divided by the square of the height in meters) =30, serious heart conditions (heart failure, coronary artery disease, or cardiomyopathies), diabetes mellitus, according to the guidance of Food and Drug Administration and World Health Organization (WHO)

Exclusion criteria

Exclusion criteria: 1. The use of dialysis 2. Estimated glomerular filtration rate of 30 ml/minute/1.73 m² or less 3. Pregnancy 4. Neutropenia (neutrophil count of <500 / ml) 5. Platelet count <100,000/microliter 6. Monoclonal antibodies 7. Remdesivir

Design outcomes

Primary

MeasureTime frame
Measured using patient records: Adverse events are measured by seeing patients, 7, 14, 21 and 28 days. 1. Nausea, vomiting, anaphylaxis, and disturbance are measured within 7 days. 2. Massive sputum, anorexia and hypoxia are within 14 days. 3. Feeling dizzy, headaches and diarrhea are within 21 days. 4. Inedia and melena are within 28 days.

Secondary

MeasureTime frame
Measured based on the results of the clinical diagnosis by the attending physician: 1. Efficacy at 7 days 2. Safety within 28 days

Countries

Japan

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026