Chikungunya Virus InfectionConvictionCHIKNCT07190560
Against Chikungunya Virus and Neonatal Infection
A study testing plasma transfusion : PC-CHIK-V in people with Chikungunya Virus Infection and Neonatal, run by Centre Hospitalier Universitaire de la Réunion at 3 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 0 to 2 days
- Conditions the study is for
- Chikungunya Virus Infection, Neonatal, Transfusion
- What is being tested?
- plasma transfusion : PC-CHIK-V
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 1 Aug 2027to 1 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 2 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 3 countries
France1 site, 1 recruiting
- Not yet recruiting
CHU La Réunion
Saint-Pierre, 97410
IACOBELLI, +262262359000, promotion.drci@chu-reunion.fr
Duksha RAMFUL, Dr
French Guiana1 site, 1 recruiting
- Recruiting
CHU de Guyane , site de Cayenne
Cayenne
Dr AGBESSY, 05 94 39 50 50 ext. +594, ahouwanou.agbessy@ch-cayenne.fr
Mayotte1 site, 1 recruiting
- Recruiting
Centre hospitalier de Mayotte
Mamoudzou
Soumeth ABASSE, +262 269 61 80 00, nouriati.toumbou@chmayotte.fr
About this study
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:
Read more
- 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
- Conditions
- Chikungunya Virus Infection, Neonatal, Transfusion, Encephalopathy
- Being tested
- plasma transfusion : PC-CHIK-V
- Medical subject headings
- Chikungunya Fever, Brain Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
plasma transfusion : PC-CHIK-VBiological
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
| Study group | Role | What they receive |
|---|---|---|
| Plasma transfusion in newborns whose mothers are infected with chikungunya around the time of birth. | Experimental | Biological and medical examination from Day 1 to Day 7 and at a visit between 1 and 3 months Receives: Biological: plasma transfusion : PC-CHIK-V |
| Parallel observational cohort | No intervention | No intervention, secondary using of care data collected, during standard cares, for the research |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Five days after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2025
- Study start1 Aug 2027 (estimated)
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chikungunya Virus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Réunion
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07190560
- Sponsor's protocol ID
- 2025/RUN/0036
- Acronym
- ConvictionCHIK
- Status last verified
- Sep 2026
- First submitted
- 17 Sep 2025
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Against Chikungunya Virus and Neonatal Infection
- ClinicalTrials.gov ID
- NCT07190560
- Acronym / sponsor ID
- ConvictionCHIK / 2025/RUN/0036
- Conditions
- Chikungunya Virus Infection, Neonatal, Transfusion, Encephalopathy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de la RéunionUniversity, hospital or other
- Study start
- 1 Aug 2027 (estimated)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 Dec 2029 (estimated)
- First posted
- 24 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plasma transfusion in newborns whose mothers are infected with chikungunya around the time of birth. | Experimental | Biological: plasma transfusion : PC-CHIK-VBiological and medical examination from Day 1 to Day 7 and at a visit between 1 and 3 months |
| Parallel observational cohort | No intervention | –No intervention, secondary using of care data collected, during standard cares, for the research |
Who may qualify
- Ages
- 0 to 2 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (15 listed)
- Treatment group
- 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):
- Whose holders of parental authority have given free, informed, and written consent prior to any examination required for the research. Parallel Cohort of
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| plasma transfusion : PC-CHIK-Vplasma 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 | Biological | Plasma transfusion in newborns whose mothers are infected with chikungunya around the time of birth. |
Primary outcome
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.
Time frame: Five days after inclusion
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Derived from this study: PubMed 42174470Iacobelli 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
CHU de Guyane , site de Cayenne
Cayenne, French Guiana
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing plasma transfusion : PC-CHIK-V in people with Chikungunya Virus Infection and Neonatal, run by Centre Hospitalier Universitaire de la Réunion at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France, French Guiana, Mayotte. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Five days after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07190560, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.