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RecruitingNCT07190560ConvictionCHIKUpdated Sep 15, 2026

Against Chikungunya Virus and Neonatal Infection

An interventional study of plasma transfusion : PC-CHIK-V in Chikungunya Virus Infection, Neonatal and Transfusion, sponsored by Centre Hospitalier Universitaire de la Réunion. Recruiting at 3 sites in 3 countries. Open to participants aged 0 Days to 2 Days. Per ClinicalTrials.gov, last updated 2026-09-15.

Sponsored by Centre Hospitalier Universitaire de la Réunion · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
0 Days to 2 Days
Sex
All
01

Study summary

The goal of this clinical trial is to learn if administration of plasma, from a whole blood donation from an individual who has declared a Chikungunya infection for less than 6 months , to a newborn, whose mother has a peripartum chikungunya infection, will have an impact on the proportion of newborns surviving without encephalitis/encephalopathy (EE) within the first 5 days of life. Researchers will compare results to an observational study of 30 newborns who couldn't have been proposed to participate at the clinical trial, because of delay of diagnosis or delay of transfer to hospital which doesn't allow transfusion or parents not accepting plasma transfusion to the newborn.

Participants of the clinical trial will:

  • receive a transfusion,
  • visit the clinic and undergo biological tests every day until day 7 and once between 1 and 3 months.

Participant of observational study as part of their regular medical care, and biological data will be reused for the research from the mother's diagnosis until the newborn reaches 3 months of age

02

Conditions studied

  • Chikungunya Virus Infection
  • Neonatal
  • Transfusion
  • Encephalopathy
03

In context

Chikungunya Fever

88 studies on the registry are indexed under Chikungunya Fever; 21 are open to participants now.

This study's planned enrollment of 60 is below the median of 263 across 57 interventional studies indexed under Chikungunya Fever.

Browse Chikungunya Fever studies →

Lead sponsor

Centre Hospitalier Universitaire de la Réunion is the lead sponsor of 141 studies on the registry; 37 are open to participants now.

Browse Centre Hospitalier Universitaire de la Réunion studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
0 Days to 2 Days
Sexes eligible
All
Accepts healthy volunteers
No

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.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Plasma transfusion in newborns whose mothers are infected with chikungunya around the time of birth.

    Biological and medical examination from Day 1 to Day 7 and at a visit between 1 and 3 months

    Biological: plasma transfusion : PC-CHIK-V

  • No intervention
    Parallel observational cohort

    No intervention, secondary using of care data collected, during standard cares, for the research

Interventions

  • Biologicalplasma transfusion : PC-CHIK-V

    plasma transfusion , from donation from an individual who has declared a Chikungunya infection for less than 6 months , to a newborn, whose mother has a peripartum chikungunya infection

06

What researchers measure

Primary outcomes

  1. Evaluate the efficacy of early administration of PC-CHIK-V in preventing the occurrence of neonatal CHIK-V encephalitis/encephalopathy (EE) in newborns whose mothers have peripartum CHIK-V infection.

    The primary outcome measure is the proportion of newborns treated with PC-CHIK-V surviving without encephalitis/encephalopathy (EE) within the first 5 days of life.

    Time frame: Five days after inclusion

07

Study locations

2 of 3 sites recruiting
08

References and documents

Publications

  • Iacobelli S, Laperche S, Pasquet A, Papa K, Maccio G, Guinaud J, Abasse S, Bardou M, Ferdynus C; CONVICTION-CHIK study group. CONVICTION-CHIK study on the effect of convalescent plasma for mother-to-child Chikungunya infection: protocol for a multicentre, open label, single-arm, phase II trial. BMC Pregnancy Childbirth. 2026 May 22;26(1):778. doi: 10.1186/s12884-026-09311-x. PubMed 42174470 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Aug 2027; primary completion for Oct 2028, 14 months later.

Of 14 interventional studies with no phase under Chikungunya Fever, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 41. This study's planned 14 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 17, 2025
First posted
Sep 24, 2025
StartEst.
Aug 1, 2027
Primary completionEst.
Oct 1, 2028
CompletionEst.
Dec 1, 2029
Last update
Sep 15, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07190560
Lead sponsor
Centre Hospitalier Universitaire de la Réunion
Responsible party
Sponsor
First posted
Sep 24, 2025
Start date
Aug 1, 2027 (estimated)
Primary completion
Oct 1, 2028 (estimated)
Completion
Dec 1, 2029 (estimated)
Last update
Sep 15, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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