New treatment options for hospitalized people with Lassa fever in West Africa

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

INTEGRATE is a multinational, multicentre, randomized, open-label platform that moves seamlessly from phase II to phase III to compare multiple investigational drugs against standard of care in hospitalized Lassa fever patients. Participants are randomized to one of several arms including favipiravir, ribavirin, dexamethasone, or high- and low-dose ARN-75039, with outcomes compared to the local standard-of-care drug. The primary outcome is prevention of death or organ failure, while secondary work includes safety, virology, biological markers, and pharmacokinetic/pharmacodynamic modelling to guide dosing. The trial is conducted at participating hospitals in West Africa with coordination among academic and clinical partners.

Why it matters

Who can join: the full rules

1. General

   Inclusion criteria
   * Clinical disease with signs and symptoms suggestive for LF
   * Positive plasma LASV RT-PCR
   * Participant requires hospitalization per the local guidelines
   * Participant or their legally authorized representative is able and willing to sign the informed consent

   Exclusion criteria
   * Unwilling to provide informed consent
   * Positive pregnancy test
   * Unwilling to provide informed consent
   * History of allergic reaction or other contra-indication to ribavirin according to the Reference safety document
   * Received drug therapy for Lassa fever (excluding supportive care) prior to inclusion
   * Has received a vaccine against LF
2. Sub-protocols

   2.1 Favipiravir high dose sub-protocol

   Inclusion criteria • Age ≥ 18 years old

   Exclusion criteria • Pregnancy (evidenced by positive urine pregnancy test in women of child-bearing potential)
   * Treatment contraindicated with favipiravir according to the Reference safety document
   * Pre-existing liver failure
   * Severe symptomatic gout/hyperuricemia
   * History of QT prolongation or arrhythmia or other cardiac disorders
   * PR interval ≥ 200 ms
   * Hypersensitivity to excipients
   * Inability to take oral drug (e.g. encephalopathy, severe vomiting)

   2.2. Favipiravir-Ribavirin sub-protocol

   Inclusion criteria

   • Age ≥ 18 years old

   Exclusion criteria
   * Pregnancy (evidenced by positive urine pregnancy test in women of child-bearing potential)
   * Treatment contraindicated with favipiravir according to the Reference safety document
   * Pre-existing liver failure
   * Severe symptomatic gout/hyperuricemia
   * History of QT prolongation or arrhythmia or other cardiac disorders
   * PR interval ≥ 200 ms
   * Hypersensitivity to excipients
   * Inability to take oral drug (e.g. encephalopathy, severe vomiting)

   2.3. Dexamethasone sub-protocol

   Inclusion criteria • Age ≥ 12 years old

   Exclusion criteria

   • Pregnancy (evidenced by positive urine pregnancy test in women of child-bearing potential)

   • Known intolerance and contra-indications to ribavirin or dexamethasone

   • Patients who already received a corticosteroid within the preceding 7 days

   2.4 ARN-75039 subprotocols

   Exclusion criteria • History of severe gastrointestinal disease

   • History of chronic generalized pruritus
   * History of severe chronic liver disease
   * History of severe cardiac disorder

Where it's running

• Irrua Specialist Teaching Hospital
  Irrua, Edo, Nigeria Recruiting
• Federal Medical Center Owo
  Owo, Ondo State, Nigeria Recruiting
• Phebe Hospital
  Suacoco, Bong County, Liberia Not yet recruiting
• Abubakar Tafawa Balewa University Teaching Hospital
  Bauchi, Nigeria Not yet recruiting

Study contacts

• Principal investigator: Sylvanus OKOGBENIN, MD — Irrua Specialist Teaching Hospital Irrua - Edo State, Nigeria
• Study coordinator: Camille FRITZELL, PHD
• Email: camille.fritzell@coral.alima.ngo
• Phone: +33 6 58 80 90 12

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Lassa Fever Vaccine for Adults and Children in West Africa

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.