A Phase 4 interventional study of Clesrovimab in RSV Infection, sponsored by Emory University. Not yet recruiting at 1 site in United States. Open to participants aged Up to 8 Months. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by Emory University · Phase 4, Interventional, and Basic science
Among 145 studies in Respiratory Syncytial Virus Infections with a site in United States — 10 open to participants now, 14 under way, 4 of them phase 3. Respiratory Syncytial Virus Infections · United States.
Among the 145 studies in Respiratory Syncytial Virus Infections with a site in United States, this one is the 101st largest by planned enrollment of the 122 interventional ones that give a count, is one of 2 that started in 2026, is one of 3 in phase 4, reaches primary completion later than 10 of the 13 other live ones, and was the 145th registered.
306 studies on the registry are indexed under Respiratory Syncytial Virus Infections; 50 are open to participants now.
Browse Respiratory Syncytial Virus Infections studies →10 of the 145 studies in Respiratory Syncytial Virus Infections with a site in United States are open now. Recruiting first, the newest first:
GlaxoSmithKline · Sites in United States, Australia
Ages 18–80 · Healthy volunteers
Fred Hutchinson Cancer Center · Sites in United States
Ages 18+
Shionogi · Sites in United States, Argentina, Bulgaria and 5 more countries
Ages 18+
Pfizer · Sites in United States, Argentina, South Africa and 1 more country
Ages 0+ · Healthy volunteers
Clover Biopharmaceuticals USA, LLC · Sites in United States
Ages 60–85 · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 30 Respiratory Syncytial Virus Infections studies recruiting now, 14 (47%) set no upper age limit and 12 (40%) stop at 75 or younger; 13 take children under 18; 9 take healthy volunteers.
This study: Up to 8 Months · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
145 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 59 · Phase 2 40 · Phase 3 29 · Phase 4 3
First in 1997; this study’s year is marked. 2 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 24 is below the median of 89 across 223 interventional studies indexed under Respiratory Syncytial Virus Infections.
Median enrollment 88 across the 122 interventional studies, 300 across the 23 observational. Of the 127 that completed or were terminated, 61 (48%) have results posted.
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106 of 145 have an industry lead sponsor. The 10 most frequent:
Emory University is the lead sponsor of 1,405 studies on the registry; 225 are open to participants now.
Of its 237 completed or terminated interventional studies of FDA-regulated products, 178 (75%) have results posted.
Emory University has 1 study filed under Respiratory Syncytial Virus Infections — fewer than ten, so there is no comparison to draw.
5 of the studies in Respiratory Syncytial Virus Infections with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05026749Phase 3University of Alabama at BirminghamAzithromycin Treatment for Respiratory Syncytial Virus-induced Respiratory Failure in Children | 2027-07-01 |
| NCT07214571ShionogiA Study of S-337395 in Symptomatic Nonhospitalized Adults With Respiratory Syncytial Virus (RSV) Who Are at High Risk of Progression to Severe Disease | 2026-12-30 |
| NCT07092865GlaxoSmithKlineA Study Evaluating Persistence of the Immune Response of the Adjuvanted Respiratory Syncytial Virus (RSV) Vaccine and the Safety and Immune Response Following Revaccination in Adults 18 Years of Age and Above Who Received Lung or Kidney Transplant | 2027-01-12 |
| NCT06686654Sanofi Pasteur, a Sanofi CompanyStudy of a Human Metapneumovirus/Respiratory Syncytial Virus mRNA Vaccine Candidate Encapsulated in a Lipid Nanoparticle-based Formulation in Adults Aged 60 Years and Older | 2027-01-18 |
| NCT06817889Fred Hutchinson Cancer CenterRemdesivir for the Treatment of Upper Respiratory Tract Infection Due to RSV in Immunocompromised Individuals | 2027-11-30 |
Add all 5 to your calendar (.ics) → With an account.
Among the 145 studies in Respiratory Syncytial Virus Infections with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
Clesrovimab is an FDA-approved antibody drug recommended for infants younger than 8 months who are entering their first respiratory syncytial virus (RSV) season and whose mothers did not receive an RSV vaccine during pregnancy. It is given to help prevent severe RSV illness. This study will measure clesrovimab and other RSV antibodies in infants' blood and noses to learn how much of the drug reaches the nose, how long the antibodies remain, and how antibody levels change if an infant becomes infected with RSV.
The study will enroll 24 infants younger than 8 months who are entering their first RSV season. The study includes minors and may include newborn infants. Written permission will be obtained from a parent or legally authorized representative before any study procedures occur. Infant assent will not be obtained because the participants are too young to provide it.
Each infant will receive one injection of clesrovimab as part of the usual care recommended to prevent serious RSV illness. Study staff will collect blood and nasal samples before the injection, at either Day 8 or Day 45, and at Day 181 after injection. Parent or legally authorized representative will also complete one safety follow-up visit by phone call at either Day 8 or Day 45.
Each infant will participate for about six months after receiving clesrovimab. Recruitment will invite families of eligible infants through the Emory Children's Center-Vaccine Research Clinic (ECC-VRC), Emory and community outreach, healthcare clinics, electronic health record messages, advertisements, and approved online recruitment methods.
Blood, nasal samples, and study data will be stored for the planned study tests. Remaining samples will be stored without information that directly identifies the infant, such as the infant's name or date of birth (de-identified), until the planned tests are complete and the study is closed. They will not be stored for unrelated future research. Study records will be kept as required by Emory, the study sponsor, and applicable rules.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive a single injection of clesrovimab intramuscularly in the anterolateral thigh at a dose of 105 mg, at Visit 1 (Day 1).
Biological: Clesrovimab
Clesrovimab (ENFLONSIA™) is a commercially available product that is administered as part of standard-of-care RSV prevention.
Also known as: Enflonsia™
Geometric mean concentration (GMC) of serum RSV pre-fusion (preF) binding IgG antibodies
RSV pre-fusion (preF) IgG binding antibodies in serum specimens will be quantified. Assay results will be reported as concentrations (arbitrary units per milliliter, AU/mL) derived from a calibrated standard curve. Serum RSV preF IgG concentrations will be summarized as geometric mean concentrations (GMC) at each study timepoint.
Time frame: Baseline (Day 1), assigned early follow-up timepoint (Day 8 or Day 45) and Day 181
Geometric mean concentration (GMC) of nasal RSV pre-fusion (preF) binding IgG antibodies
RSV pre-fusion (preF) IgG binding antibodies in nasal specimens will be quantified. Assay results will be reported as concentrations (arbitrary units per milliliter, AU/mL) derived from a calibrated standard curve. For nasal specimens, RSV preF IgG concentrations will be normalized to total human IgG concentration. Normalized nasal antibody values will be summarized as GMC.
Time frame: Baseline (Day 1), assigned early follow-up timepoint (Day 8 or Day 45) and Day 181
Geometric mean titers (GMT) of serum RSV-A neutralizing antibodies
Serum RSV neutralizing antibody titers will be measured using a microneutralization assay. Neutralizing antibody titers will be reported as reciprocal dilution EC50 titers (the serum dilution resulting in 50% neutralization) and summarized as geometric mean titers (GMTs).
Time frame: Baseline (Day 1), assigned early follow-up timepoint (Day 8 or Day 45) and Day 181
Serum Geometric mean concentration (GMC) of clesrovimab
Serum clesrovimab concentrations will be reported in concentration units and summarized as geometric mean concentrations (GMC) at each study timepoint.
Time frame: Baseline (Day 1), assigned early follow-up timepoint (Day 8 or Day 45) and Day 181
Urea-normalized GMC of clesrovimab in the nasal mucosa
Clesrovimab concentrations will be normalized to urea concentration for nasal samples to account for variability in epithelial lining fluid dilution. Urea-normalized nasal clesrovimab concentrations will be summarized as GMC.
Time frame: Baseline (Day 1), assigned early follow-up timepoint (Day 8 or Day 45) and Day 181
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Mar 2028, 16 months later.
Start moved once since we started tracking on Sep 25, 2026: Sep 2026 → Nov 2026, on Nov 12, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Clesrovimab
Respiratory Syncytial Virus Infections →