Safety of oral molnupiravir administration for hospitalized elderly COVID-19 patients aged 80 years old or older
| ISRCTN | ISRCTN79981540 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN79981540 |
- Submission date
- 11/07/2022
- Registration date
- 15/07/2022
- Last edited
- 21/07/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
Oral molnupiravir has been found to be effective in the treatment of Covid-19 if it is initiated within 5 days after the onset of signs or symptoms in nonhospitalized, unvaccinated adults who were at risk of progression to serious disease, without obvious safety concerns. We evaluated the efficacy and safety of oral administration of molnupiravir to hospitalized elderly patients.
Who can participate?
Elderly people over 80 years of age with a risk factor for severe Covid-19
What does the study involve?
All participants receive molnupiravir within 24 hours of displaying symptoms of Covid-19
What are the possible benefits and risks of participating?
Oral administration of molnupiravir in the elderly aged 80 years and older is effective and is considered to potentially significantly improve outcomes.
If serious side effects are observed during oral administration, the administration should be stopped immediately. Safety monitoring was performed by the Data Monitoring Committee.
Where is the study run from?
Daido Central Hospital (Japan)
When is the study starting and how long is it expected to run for?
May 2022 to June 2022
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Kenji Gonda, gondake@fmu.ac.jp
Contact information
Scientific
1-1-37 Asato
Naha
Okinawa
902-0067
Japan
 ORCID ID |
0000-0002-7671-1808 |
|---|---|
| Phone | +81-98-869-0005 |
| gondake@fmu.ac.jp |
Study information
| Study design | Single centre longitudinal case-control study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Longitudinal study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not applicable (retrospective study) |
| Scientific title | Early treatment with molnupiravir in the elderly at risk for Covid-19 |
| Study objectives | We evaluated the efficacy and safety of treatment with Molnupiravir. |
| Ethics approval(s) | Approved 20/06/2022, Institutional Review Board of Daido Central Hospital, Daido Central Hospital, 1-1-37 Asato, Naha, Okinawa 902-0067, Japan; +81-98-869-0005; gondake@fmu.ac.jp), ref: No.35 |
| Health condition(s) or problem(s) studied | Hospitalized elderly with at least one risk factor for Covid-19 disease |
| Intervention | 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 with at least one risk factor for Covid-19 disease confirmed in the laboratory. The follow-up observation period was 28 days during the treatment period and after the end of the treatment period, and the mortality rate was evaluated as efficacy and the adverse event incidence rate was evaluated as safety. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Molnupiravir |
| Primary outcome measure | 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 outcome measures | Measured based on the results of the clinical diagnosis by the attending physician: 1. Efficacy at 7 days 2. Safety within 28 days |
| Overall study start date | 17/05/2022 |
| Completion date | 20/06/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 29 |
| Total final enrolment | 29 |
| Key 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) |
| Key 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 |
| Date of first enrolment | 17/01/2022 |
| Date of final enrolment | 17/07/2022 |
Locations
Countries of recruitment
- Japan
Study participating centre
Naha
Okinawa
902-0067
Japan
Sponsor information
University/education
1 Hikarigaoka
Fukushima
960-1295
Japan
| Phone | +81-90-4851-7823 |
|---|---|
| suzukou8931@gmail.com | |
| Website | http://www.fmu.ac.jp/ |
"ROR" |
https://ror.org/012eh0r35 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 31/12/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository, Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a publically available repository. Now, I have no repository name/weblink. Type of data that will be shared is Fig and Table in my manuscript. The data will become available after my manuscript is accepted and forever. The data will be shared including with anyone else and all types of analyses. The study was conducted according to the guidelines of the Declaration of Helsinki, and it was registered and approved by the Institutional Review Board of Daido Central Hospital (protocol code number: No.35, Jun 2022). Written informed consent was obtained from all patients and their families. Data were collected by the investigators and attending physicians, and interpreted by the authors. Data on adverse events were collected until the end of the follow-up observation period, and they were approved from all patients and their families for their storage, analysis, utilization, and publication of the data. The authors guarantee the accuracy and integrity of the data and the fidelity of the test protocol. In accordance with the Personal Protection Law, no patient name or family name will be published, and the subject patients will not be tracked or specified from this article. |
Editorial Notes
21/07/2022: The public title has been changed from "Safety of oral administration of molnupiravir for hospitalized elderly people aged 80 years old or older with Covid-19" to "Safety of oral molnupiravir administration for hospitalized elderly COVID-19 patients aged 80 years old or older".
12/07/2022: Trial's existence confirmed by Ministry of Health, Labour and Welfare
