Trial · NCT05559905
Respiratory Syncytial Virus (RSV) Human Challenge Study of Molnupiravir in Healthy Participants (MK-4482-017)
NCT05559905, Phase 2, Completed, Merck Sharp & Dohme LLC; results first posted 2024-05-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Respiratory Syncytial Virus (RSV) Human Challenge Study of Molnupiravir in Healthy Participants (MK-4482-017). Trials, record NCT05559905. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05559905
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Respiratory Syncytial Virus (RSV) Human Challenge Study of Molnupiravir in Healthy Participants (MK-4482-017)
- NCT number
- NCT05559905
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 116 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Respiratory Syncytial Virus
- Interventions
- Molnupiravir, Placebo, RSV A Memphis 37b
- First posted
- 2022-09-29
- Last updated
- 2025-07-18
- Results first posted
- 2024-05-20
Source ClinicalTrials.gov
Registered outcomes33
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Panel A vs Panel C: Peak Viral Load (PVL) Determined by Viral Quantitative Culture | From Day 2 up to Day 12 | PVL was defined as the maximum viral load during a specified time period. PVL determined by viral quantitative culture (plaque assay) was measured from Day 2 up to Day 12 (end of participant quarantine). PVL (on the log10 scale) of RSV A Memphis 37b determined by viral quantitative culture (plaque assay) between Day 2 and Day 12 am after intranasal inoculation (Day 0) was analyzed using a linear model with treatment group as a fixed categorical effect. Per protocol, only Panel A (prophylaxis) and Panel C (placebo) were included in the model. |
| Primary | Panel B vs. Panel C: Area Under the Viral Load-time Curve (VL-AUC) Determined by Viral Quantitative Culture | From Day 2 up to Day 12 | VL-AUC between Day 2 and Day 12 after intranasal inoculation (Day 0) was computed for each participant, based on RSV viral load determined by viral quantitative culture (plaque assay) from nasal wash samples collected twice daily (morning and evening). In order to calculate the AUC, the actual time that the assessment was collected was used within the AUC calculation. VL-AUC (on the log10 scale) was analyzed using a linear model with treatment group as a fixed categorical effect. Per protocol, only Panel B (treatment) and Panel C (placebo) were included in the model. For both panels, only the participants with RSV infection were included. |
| Secondary | All Panels: Number of Participants Who Experienced ≥1 Adverse Event (AE) | From Day -1 up to Day 28 | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experienced an AE is reported. |
| Secondary | All Panels: Number of Participants Who Experienced ≥1 Serious AE (SAE) | From Day -1 up to Day 28 | An SAE is any untoward medical occurrence that, at any dose, results in death; is life-threatening; requires hospitalization or prolongs existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly or birth defect; or is another important medical event such as invasive/malignant cancers or substance abuse/dependency. The number of participants who experienced an SAE is reported. |
| Secondary | All Panels: Number of Participants Who Experienced ≥1 Viral Challenge-Related AE | From Day 0 up to Day 28 | A viral challenge-related AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, that was considered related to the viral challenge (inoculation). The number of participants who experienced AEs related to the viral challenge from viral challenge (Day 0) up to the Day 28 follow-up is reported. |
| Secondary | All Panels: Number of Participants Who Experienced ≥1 Viral Challenge-Related SAE | From Day 0 up to Day 28 | A viral challenge-related SAE was defined as any untoward medical occurrence that, at any dose, resulted in death; was life-threatening; required hospitalization or prolonged existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly or birth defect; or was another important medical event, that was considered related to the viral challenge (inoculation). The number of participants who experienced SAEs related to the viral challenge from viral challenge (Day 0) up to the Day 28 follow-up is reported. |
| Secondary | All Panels: Number of Participants Using Concomitant Medications From Viral Challenge Through Day 28 | From Day 0 up to Day 28 | Concomitant medications were defined as any prescription medications, over the counter drugs or dietary supplements that a participant happened to be taking while on study, in addition to molnupiravir. The number of participants using concomitant medications from viral challenge (Day 0) up through Day 28 is reported. |
| Secondary | Panel A vs. Panel C: VL-AUC Determined by Viral Quantitative Culture | From Day 2 up to Day 12 | VL-AUC between Day 2 and Day 12 after intranasal inoculation (Day 0) was computed for each participant, based on RSV viral load determined by viral quantitative culture (plaque assay) from nasal wash samples collected twice daily (morning and evening). In order to calculate the AUC, the actual time that the assessment was collected was used within the AUC calculation. VL-AUC (on the log10 scale) was analyzed using a linear model with treatment group as a fixed categorical effect. Per protocol, only Panel A (prophylaxis) and Panel C (placebo) were included in the model. |
| Secondary | Panel A vs. Panel C: VL-AUC Determined by Real-time Quantitative Reverse Transcription Polymerase Chain Reaction (qRT-PCR) | Day 2 up through Day 12 | VL-AUC between Day 2 and Day 12 after intranasal inoculation (Day 0) was computed for each participant, based on RSV viral load determined by qRT-PCR from nasal wash samples collected twice daily (morning and evening). In order to calculate the AUC, the actual time that the assessment was collected was used within the AUC calculation. VL-AUC (on the log10 scale) was analyzed using a linear model with treatment group as a fixed categorical effect. Per protocol, only Panel A (prophylaxis) and Panel C (placebo) were included in the model. |
| Secondary | Panel A vs. Panel C: PVL Determined by qRT-PCR | Day 2 up through Day 12 | PVL was defined as the maximum viral load during a specified time period. PVL as determined by qRT-PCR was measured starting from Day 2 up to planned discharge from quarantine (Day 12 am). Nasal wash samples were collected and tested for RSV viral load by qRT-PCR twice daily from Day 2 through Day 11. A single nasal wash sample for RSV viral load by qRT-PCR was collected on Day 12. PVL by qRT-PCR was analyzed using a linear model with treatment group as a fixed categorical effect. Per protocol, only Panel A (prophylaxis) and Panel C (placebo) were included in the model. |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 registered outcomesOutcomes33
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Panel A vs Panel C: Peak Viral Load (PVL) Determined by Viral Quantitative Culture | From Day 2 up to Day 12 | All randomized participants in Panel A or Panel C who received 1 dose of the correct clinical material corresponding to the treatment group the participants were randomized into, who received the viral inoculation, and had available PVL viral quantitative culture data. Per protocol, Panel B was not included in this analysis. | log10 plaque forming units (PFU)/mL | LEAST_SQUARES_MEAN |
| PRIMARY | Panel B vs. Panel C: Area Under the Viral Load-time Curve (VL-AUC) Determined by Viral Quantitative Culture | From Day 2 up to Day 12 | All randomized participants in Panel B or Panel C who received 1 dose of the correct clinical material corresponding to the treatment group the participants were randomized into, who received the viral inoculation, were determined to be RSV infected, and had available VL-AUC viral quantitative culture data. Per protocol, Panel A was not included in this analysis. | day*log10 PFU/mL | LEAST_SQUARES_MEAN |
| SECONDARY | All Panels: Number of Participants Who Experienced ≥1 Adverse Event (AE) | From Day -1 up to Day 28 | All participants who received at least one dose of treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | All Panels: Number of Participants Who Experienced ≥1 Serious AE (SAE) | From Day -1 up to Day 28 | All participants who received at least one dose of treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | All Panels: Number of Participants Who Experienced ≥1 Viral Challenge-Related AE | From Day 0 up to Day 28 | All participants who received at least one dose of treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | All Panels: Number of Participants Who Experienced ≥1 Viral Challenge-Related SAE | From Day 0 up to Day 28 | All participants who received at least one dose of treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | All Panels: Number of Participants Using Concomitant Medications From Viral Challenge Through Day 28 | From Day 0 up to Day 28 | All participants who received at least one dose of treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Panel A vs. Panel C: VL-AUC Determined by Viral Quantitative Culture | From Day 2 up to Day 12 | All randomized participants in Panel A or Panel C who received 1 dose of the correct clinical material corresponding to the treatment group the participants were randomized into, who received the viral inoculation, and had available VL-AUC viral quantitative culture data. Per protocol, Panel B was not included in the analysis. | day*log10 PFU/mL | LEAST_SQUARES_MEAN |
| SECONDARY | Panel A vs. Panel C: VL-AUC Determined by Real-time Quantitative Reverse Transcription Polymerase Chain Reaction (qRT-PCR) | Day 2 up through Day 12 | All randomized participants in Panel A or Panel C who received 1 dose of the correct clinical material corresponding to the treatment group the participants were randomized into and who received the viral inoculation. Per protocol, Panel B was not included in the analysis. | day*log10 copies/mL | LEAST_SQUARES_MEAN |
| SECONDARY | Panel A vs. Panel C: PVL Determined by qRT-PCR | Day 2 up through Day 12 | All randomized participants in Panel A or Panel C who received 1 dose of the correct clinical material corresponding to the treatment group the participants were randomized into, who received the viral inoculation, and had available PVL qRT-PCR data. Per protocol, Panel B was not included in this analysis. | day*log10 copies/mL | LEAST_SQUARES_MEAN |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 outcomesResults by group111
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Panel A vs Panel C: Peak Viral Load (PVL) Determined by Viral Quantitative Culture | Panel A: Molnupiravir Prophylaxis | 2.55 | 95% Confidence Interval 1.81 to 3.30 | log10 plaque forming units (PFU)/mL | |
| Panel A vs Panel C: Peak Viral Load (PVL) Determined by Viral Quantitative Culture | Panel C: Matched Placebo | 2.84 | 95% Confidence Interval 2.12 to 3.57 | log10 plaque forming units (PFU)/mL | |
| Panel B vs. Panel C: Area Under the Viral Load-time Curve (VL-AUC) Determined by Viral Quantitative Culture | Panel B: Molnupiravir Triggered Treatment | 7.02 | 95% Confidence Interval 3.91 to 10.14 | day*log10 PFU/mL | |
| Panel B vs. Panel C: Area Under the Viral Load-time Curve (VL-AUC) Determined by Viral Quantitative Culture | Panel C: Matched Placebo | 9.72 | 95% Confidence Interval 6.93 to 12.50 | day*log10 PFU/mL | |
| All Panels: Number of Participants Who Experienced ≥1 Adverse Event (AE) | Panel A: Molnupiravir Prophylaxis | 13 | Participants | ||
| All Panels: Number of Participants Who Experienced ≥1 Adverse Event (AE) | Panel B: Molnupiravir Triggered Treatment | 15 | Participants | ||
| All Panels: Number of Participants Who Experienced ≥1 Adverse Event (AE) | Panel C: Matched Placebo | 13 | Participants | ||
| All Panels: Number of Participants Who Experienced ≥1 Serious AE (SAE) | Panel A: Molnupiravir Prophylaxis | 0 | Participants | ||
| All Panels: Number of Participants Who Experienced ≥1 Serious AE (SAE) | Panel B: Molnupiravir Triggered Treatment | 0 | Participants | ||
| All Panels: Number of Participants Who Experienced ≥1 Serious AE (SAE) | Panel C: Matched Placebo | 0 | Participants |
1 to 10 of 111Source ClinicalTrials.gov
See all 111 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Panel A: Molnupiravir Prophylaxis | 40 | |
| Overall Study | STARTED | Panel B: Molnupiravir Triggered Treatment | 36 | |
| Overall Study | STARTED | Panel C: Matched Placebo | 40 | |
| Overall Study | Started Study Medication | Panel A: Molnupiravir Prophylaxis | 39 | |
| Overall Study | Started Study Medication | Panel B: Molnupiravir Triggered Treatment | 36 | |
| Overall Study | Started Study Medication | Panel C: Matched Placebo | 40 | |
| Overall Study | COMPLETED | Panel A: Molnupiravir Prophylaxis | 38 | |
| Overall Study | COMPLETED | Panel B: Molnupiravir Triggered Treatment | 36 | |
| Overall Study | COMPLETED | Panel C: Matched Placebo | 40 | |
| Overall Study | NOT COMPLETED | Panel A: Molnupiravir Prophylaxis | 2 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events3
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Upper respiratory tract infection | Infections and infestations | Panel A: Molnupiravir Prophylaxis | 1 | 39 | 1 |
| other | Upper respiratory tract infection | Infections and infestations | Panel B: Molnupiravir Triggered Treatment | 2 | 36 | 2 |
| other | Upper respiratory tract infection | Infections and infestations | Panel C: Matched Placebo | 0 | 40 | 0 |
Source ClinicalTrials.gov
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Panel A: Molnupiravir Prophylaxis | 0 | 40 |
| Total, all-cause mortality | Panel B: Molnupiravir Triggered Treatment | 0 | 36 |
| Total, all-cause mortality | Panel C: Matched Placebo | 0 | 40 |
| Total, other adverse events | Panel A: Molnupiravir Prophylaxis | 1 | 39 |
| Total, other adverse events | Panel B: Molnupiravir Triggered Treatment | 2 | 36 |
| Total, other adverse events | Panel C: Matched Placebo | 0 | 40 |
| Total, serious adverse events | Panel A: Molnupiravir Prophylaxis | 0 | 39 |
| Total, serious adverse events | Panel B: Molnupiravir Triggered Treatment | 0 | 36 |
| Total, serious adverse events | Panel C: Matched Placebo | 0 | 40 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40175624 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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