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Can donated plasma shield newborns from chikungunya brain damage?

NCT ID NCT07190560

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 16, 2026 · Updated 3 times

Summary

This study tests whether giving newborns plasma from people who recently recovered from chikungunya can prevent brain swelling or damage. The trial will include 60 newborns whose mothers were infected around the time of birth. Half will receive the plasma transfusion, and their outcomes will be compared to a group of 30 similar newborns who did not receive the treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
plasma from recovered chikungunya patients
What this could lead to
If it works, this could provide a way to protect newborns from severe brain complications after chikungunya infection.
What could go wrong
This is a small, early-stage trial with only 60 participants, so results may not be conclusive. The treatment involves a plasma transfusion, which carries risks like allergic reactions or infection.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2027

An estimate. Start dates often move.

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

0 to 2 days

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Treatment group Newborn: * whose mother has a clinical and/or laboratory diagnosis of Chikungunya (CHIK) infection occurring between 2 days before and 2 days after birth. * Hospitalized in a Level III neonatology unit in Mayotte or at the University Hospital of La Réunion. * Eligible for experimental treatment (called PC-CHIK-V): * If the maternal infection was diagnosed between2 days before and the day of delivery, treatment can be administered within the first 12 hours of the newborn's life. * If the maternal infection was diagnosed between 1 day and 2 days after birth, treatment can be administered within 12 hours of diagnosis. * Whose holders of parental authority have given free, informed, and written consent prior to any examination required for the research. Parallel Cohort of Untreated Newborns (parallel observational cohort) Newborns: * Whose mother has a clinical and/or laboratory diagnosis of CHIK-V infection occurring between 2 days before and 2 days after birth. * Hospitalized in a Level III neonatology unit in Mayotte or at the University Hospital of La Réunion. * Not treated with PC-CHIK-V: * Monitored in one of the units of the Neonatology Department for at least 5 days from the day of birth. * Whose holders of parental authority (or the holder if the mother is the sole holder of parental authority) have been informed of the research and have not objected to the use of data collected during hospitalization for research purposes. Exclusion Criteria: * Newborns who present at birth with clinical criteria for ahypoxic-ischemic encephalopathy (HIE) that require therapeutic hypothermia according to the national protocol for "neonatal therapeutic hypothermia" * Newborns who require phototherapy treatment at the time of enrollment using devices with a maximum energy wavelength less than 425 nm and/or with an emission bandwidth with a lower limit of \<375 nm.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites in 3 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CHU La Réunion

    NOT_YET_RECRUITING

    Saint-Pierre, 97410, France

  • CHU de Guyane , site de Cayenne

    RECRUITING

    Cayenne, French Guiana

  • Centre hospitalier de Mayotte

    RECRUITING

    Mamoudzou, Mayotte

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