Lassa FeverLASCOPENCT03655561
Lassa Fever Clinical Course and Prognostic Factors in Nigeria
An observational study of Lassa Fever and Lassa Virus Infection, run by Alliance for International Medical Action at 2 sites in Nigeria.
Trial summary
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lassa Fever, Lassa Virus Infection, Pregnancy Complications
- What is being tested?
- Non interventional research
- Type of treatment
- Injection or infusion
- How many people
- 1,100 participants
- Where
- 2 sitesNigeria
- Study dates
- 5 Apr 2018to 26 Oct 2026
- How long will I take part?
- 60 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- EITHER admission (inpatient) for suspected or already RT-PCR confirmed Lassa fever OR newborn from woman infected with Lassa virus during pregnancy
- AND written informed consent of the patient or his/her legal representative (specific procedures for: immature minors, mature minors, incapable adults and unconscious adults; witnessed consent in case of illiteracy)
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country.
Nigeria2 sites
Alex Ekwueme Federal University Teaching Hospital Abakaliki
Abakaliki, Ebonyi State
Owo Federal Medical Centre (Owo FMC)
Owo, Ondo State, PMB 1053
About this study
Official title: Observational Cohort Study of Lassa Fever Clinical Course and Prognostic Factors in an Epidemic Context in Nigeria
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.
Read the detailed description
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.
- Conditions
- Lassa Fever, Lassa Virus Infection, Pregnancy Complications, Acute Kidney Injury, Acute Kidney Failure, Coma
- Being tested
- Non interventional research
- Keywords
- Lassa fever, Lassa virus, Nigeria, Pregnancy, Acute kidney injury
- Medical subject headings
- Lassa Fever, Pregnancy Complications, Acute Kidney Injury, Coma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non interventional researchOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Confirmed Lassa fever cases | 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 Receives: Other: Non interventional research | |
| Non-Lassa cases (controls) | Participants with a clinical presentation consistent with acute Lassa virus disease but subsequently found to have a negative result for Lassa specific RT-PCR Receives: Other: Non interventional research |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall mortality
Mortality rate among participants assessed at final visit.
Measured: 60 days after admission (day 60 after delivery for pregnant women and day 60 after birth for newborns from infected pregnant women).
Secondary outcomes (7)
Acute kidney injury
Acute kidney injury or failure according to RIFLE criteria
Measured: Within 60 days after admission
Mother status at the end of pregnancy
Is the mother dead or alive at the end of pregnancy
Measured: Delivery
Type of pregnancy termination
Spontaneous delivery, induced delivery, cesarean section, medical interruption, miscarriage
Measured: Delivery
Pregnancy complications
Reporting any type of pregnancy complications
Measured: Delivery
Newborn status at birth
Is the newborn dead or alive
Measured: Birth
Newborn status at day 30
Is the newborn dead or alive
Measured: Day 30 after birth
Newborn status at day 60
Is the newborn dead or alive
Measured: Day 60 after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start5 Apr 2018
- Primary completion30 Apr 2023
- Study completion26 Oct 2026
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 Lassa FeverStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,100 participants (actual)
- Target duration
- 60 Days
Sponsor and investigators
- Lead sponsor
- Alliance for International Medical Action
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, University of Oxford, Irrua Specialist Teaching Hospital, Bernhard Nocht Institute for Tropical Medicine, University Hospital, Bordeaux, University of Bordeaux, PACCI Program, Institut de Recherche pour le Developpement, ANRS, Emerging Infectious Diseases, Federal Medical Centre, Owo, European and Developing Countries Clinical Trials Partnership (EDCTP)
- Responsible party
- Principal investigator, Denis Malvy, Alliance for International Medical Action
- Investigators
- Denis Malvy, MD, PhD, Principal investigator, Inserm 1219 - Infectious Diseases in Ressource Limited CountriesOladele O Ayodeji, MD, Principal investigator, Owo Federal Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03655561
- Sponsor's protocol ID
- LAS001
- Acronym
- LASCOPE
- Status last verified
- Sep 2026
- First submitted
- 30 Aug 2018
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD underlying results in scientific publications will be made available through the deposition of a datafile in a public data repository.
Publications
Duvignaud A, Jaspard M, Etafo IC, Serra B, Abejegah C, Gabillard D, Doutchi M, Alabi JF, Adedokun MA, Akinpelu AO, Oyegunle OO, Etafo J, Dede AO, Onyechi MN, Ireneh MU, Gbenga-Ayeni O, Fadiminiyi KG, Ehigbor PI, Ouattara E, Levy-Marchal C, Karcher S, N'guessan-Koffi L, Ahyi I, Amani E, Diabate M, Siloue B, Schaeffer J, Augier A, Ogbaini-Emovon E, Salam AP, Horby P, Ahmed LA, Gunther S, Adedosu AN, Anglaret X, Ayodeji OO, Malvy D. Lassa fever clinical course and setting a standard of care for future randomized trials: A protocol for a cohort study of Lassa-infected patients in Nigeria (LASCOPE). Travel Med Infect Dis. 2020 Jul-Aug;36:101557. doi: 10.1016/j.tmaid.2020.101557. Epub 2020 Jan 21.
PubMed 31978611
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Cohort Study of Lassa Fever Clinical Course and Prognostic Factors in an Epidemic Context in Nigeria
- ClinicalTrials.gov ID
- NCT03655561
- Acronym / sponsor ID
- LASCOPE / LAS001
- Conditions
- Lassa Fever, Lassa Virus Infection, Pregnancy Complications, Acute Kidney Injury, Acute Kidney Failure, Coma
- Keywords
- Lassa fever, Lassa virus, Nigeria, Pregnancy, Acute kidney injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,100 participants (actual)
- Lead sponsor
- Alliance for International Medical ActionUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, University of Oxford, Irrua Specialist Teaching Hospital, Bernhard Nocht Institute for Tropical Medicine, University Hospital, Bordeaux, University of Bordeaux, PACCI Program, Institut de Recherche pour le Developpement, ANRS, Emerging Infectious Diseases, Federal Medical Centre, Owo, European and Developing Countries Clinical Trials Partnership (EDCTP)
- Study start
- 5 Apr 2018 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 26 Oct 2026 (actual)
- First posted
- 31 Aug 2018 (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 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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 60 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Confirmed Lassa fever cases | – | Other: Non interventional researchParticipants with a clinical presentation consistent with acute Lassa virus disease and a positive result for Lassa specific RT-PCR obtained before or after inclusion |
| Non-Lassa cases (controls) | – | Other: Non interventional researchParticipants with a clinical presentation consistent with acute Lassa virus disease but subsequently found to have a negative result for Lassa specific RT-PCR |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (2 listed)
- EITHER admission (inpatient) for suspected or already RT-PCR confirmed Lassa fever OR newborn from woman infected with Lassa virus during pregnancy
- AND written informed consent of the patient or his/her legal representative (specific procedures for: immature minors, mature minors, incapable adults and unconscious adults; witnessed consent in case of illiteracy)
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Non interventional researchParticipants 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. | Other | Confirmed Lassa fever cases, Non-Lassa cases (controls) |
Primary outcome
Overall mortality
Time frame: 60 days after admission (day 60 after delivery for pregnant women and day 60 after birth for newborns from infected pregnant women).
Mortality rate among participants assessed at final visit.
7 secondary outcomes
Acute kidney injury
Time frame: Within 60 days after admission
Mother status at the end of pregnancy
Time frame: Delivery
Type of pregnancy termination
Time frame: Delivery
Pregnancy complications
Time frame: Delivery
Newborn status at birth
Time frame: Birth
Newborn status at day 30
Time frame: Day 30 after birth
Newborn status at day 60
Time frame: Day 60 after birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Derived from this study: PubMed 31978611Duvignaud A, Jaspard M, Etafo IC, Serra B, Abejegah C, Gabillard D, Doutchi M, Alabi JF, Adedokun MA, Akinpelu AO, Oyegunle OO, Etafo J, Dede AO, Onyechi MN, Ireneh MU, Gbenga-Ayeni O, Fadiminiyi KG, Ehigbor PI, Ouattara E, Levy-Marchal C, Karcher S, N'guessan-Koffi L, Ahyi I, Amani E, Diabate M, Siloue B, Schaeffer J, Augier A, Ogbaini-Emovon E, Salam AP, Horby P, Ahmed LA, Gunther S, Adedosu AN, Anglaret X, Ayodeji OO, Malvy D. Lassa fever clinical course and setting a standard of care for future randomized trials: A protocol for a cohort study of Lassa-infected patients in Nigeria (LASCOPE). Travel Med Infect Dis. 2020 Jul-Aug;36:101557. doi: 10.1016/j.tmaid.2020.101557. Epub 2020 Jan 21.
- Individual participant dataSharing planned: Yes. IPD underlying results in scientific publications will be made available through the deposition of a datafile in a public data repository.
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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. This study is not recruiting at the moment.
Denis Malvy, MD, PhD principal investigator
Inserm 1219 - Infectious Diseases in Ressource Limited Countries
Oladele O Ayodeji, MD principal investigator
Owo Federal Medical Centre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lassa Fever and Lassa Virus Infection, run by Alliance for International Medical Action at 2 sites in Nigeria.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Nigeria. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall mortality (time frame: 60 days after admission (day 60 after delivery for pregnant women and day 60 after birth for newborns from infected pregnant women).). 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 NCT03655561, 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 28 Oct 2026.