An observational study in Lassa Fever, Lassa Virus Infection and Pregnancy Complications, sponsored by Alliance for International Medical Action. Active, not recruiting at 2 sites in Nigeria. Per ClinicalTrials.gov, last updated 2025-01-29.
Sponsored by Alliance for International Medical Action · Observational
The investigators propose to conduct a nationwide (Nigeria), prospective, non-interventional cohort study describing the clinical course, biological characteristics, case management and outcomes in patients hospitalized for a suspected or confirmed diagnosis of Lassa fever in tertiary medical facilities situated in the most affected Nigerian states. Special focuses will be made on situations at risk of bad outcome such as pregnancies, acute kidney injury and electrolytic imbalance in patients with confirmed Lassa fever. Participants for which the diagnosis of Lassa fever will be finally excluded by reverse-transcriptase polymerase chain reaction (RT-PCR) will constitute the control group.
The LASCOPE project refers to a nationwide, prospective, non-interventional cohort study describing the clinical course, biological characteristics, case management and outcomes in patients hospitalized for a suspected or already RT-PCR confirmed diagnosis of Lassa fever in tertiary medical facilities situated in the most affected Nigerian states. The project will start during the 2018 Lassa fever season and is intended to be extended to at least three sites throughout Nigeria on a 3 years period.
The investigators will try to depict the pathophysiological mechanisms underlying the conditions associated to a fatal outcome in patients with RT-PCR confirmed Lassa fever, with a special focus on pregnancies, acute renal injury and electrolytic imbalance.
Population and setting - Participants will be recruited in tertiary reference hospitals for Lassa fever case management in the Nigerian States identified to have the highest burden, including Owo Federal Medical Center (OFMC), Owo, Ondo State as a pilot site (list to be completed according to the outbreak dynamics).
Inclusion criteria - All the patients hospitalized for suspected or already RT-PCR confirmed Lassa fever will be eligible (no age restriction). Newborns from mothers participating in the study will also be eligible.
Sample size - Given the descriptive purpose of the study, there is no pre-determined sample size.
Follow-up - After informed consent collection, data concerning the patient's life habits, contacts, disease history, clinical and biological status, management and outcome will be collected anonymously upon admission and throughout the hospital stay. The follow-up will end 60 days after admission (60 days after delivery for pregnant women and 60 days after birth for newborns) with a phone call or a home visit (or an outpatient visit at hospital if needed).
Leftover biological samples, if any, will be stored for further analysis with the participant's agreement. The biobank will be registered once constituted and further use of stored samples will be subject to material transfer agreements.
445 studies on the registry are indexed under Pregnancy Complications; 118 are open to participants now.
This study's planned enrollment of 1,200 is above the median of 322 across 209 observational studies indexed under Pregnancy Complications.
Browse Pregnancy Complications studies →Alliance for International Medical Action is the lead sponsor of 13 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
All the patients admitted in an isolation ward of one of the participating sites (tertiary hospitals) in Nigeria for a suspected or already RT-PCR confirmed diagnosis of Lassa fever during the study period are eligible to participate in LASCOPE.
The newborns from women infected by Lassa virus (RT-PCR confirmed) during their pregnancy are also eligible to participate, with the mother's agreement.
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:
Participants with a clinical presentation consistent with acute Lassa virus disease and a positive result for Lassa specific RT-PCR obtained before or after inclusion
Other: Non interventional research
Participants with a clinical presentation consistent with acute Lassa virus disease but subsequently found to have a negative result for Lassa specific RT-PCR
Other: Non interventional research
Participants are receiving the standard of care according to Nigerian Center for Disease Control (NCDC) Standard Operating Procedures for Lassa fever case management. This include the administration of intravenous ribavirin for Lassa confirmed cases as well as critically-ill Lassa suspected cases.
Overall mortality
Mortality rate among participants assessed at final visit.
Time frame: 60 days after admission (day 60 after delivery for pregnant women and day 60 after birth for newborns from infected pregnant women).
Acute kidney injury
Acute kidney injury or failure according to RIFLE criteria
Time frame: Within 60 days after admission
Mother status at the end of pregnancy
Is the mother dead or alive at the end of pregnancy
Time frame: Delivery
Type of pregnancy termination
Spontaneous delivery, induced delivery, cesarean section, medical interruption, miscarriage
Time frame: Delivery
Pregnancy complications
Reporting any type of pregnancy complications
Time frame: Delivery
Newborn status at birth
Is the newborn dead or alive
Time frame: Birth
Newborn status at day 30
Is the newborn dead or alive
Time frame: Day 30 after birth
Newborn status at day 60
Is the newborn dead or alive
Time frame: Day 60 after birth
Plan to share: Yes — IPD underlying results in scientific publications will be made available through the deposition of a datafile in a public data repository.
Supporting information: Study protocol
Time frame: Upon publication of related scientific works (undefined duration).
Access criteria: Free access.
This study is active, not recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Alliance for International Medical Action