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Phase I Safety and Dose finding Trial of Sevuparin in children with severe malaria

A Phase I Trial of Sevuparin in severe malaria as a potential adjunctive treatment

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
PACTR
Registry ID
PACTR202007890194806
Enrollment
20
Registered
2020-07-02
Start date
2020-07-15
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malaria

Interventions

control

Sponsors

Imperial College London
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged between 3 months and 12 years admitted to the paediatric wards within the last 24h 2. Current or recent evidence of P. falciparum malaria (slide positive) 3. Clinical evidence of severe malaria (impaired consciousness or deep breathing) 4. Lactate > 2 mmol/L 5. Guardian or parent willing and able to provide consent

Exclusion criteria

Exclusion criteria: 1. Clinical evidence or a history of a bleeding/coagulation disorder 2. A comorbidity which clinician believes has a significant risk of poor outcome e.g. malignancy, end-stage renal failure, major cardiac condition 3. Thrombocytopenia (platelet count <25 x109/L).

Design outcomes

Primary

MeasureTime frame
?APTT>2.5 x upper limit of normal 1h post any sevuparin dose

Secondary

MeasureTime frame
? Change in lactate from 0 to 8 hours;Presence of mature infected erythrocytes on the blood films at 8 and 24 hours;APTT 24h post enrolment ;Neurological sequelae through day 28;Mortality to Day 28;Serious adverse events through day 28 Grade 3/4 adverse events through day 28

Countries

Kenya, Zambia

Contacts

Public ContactEmmanuel Oguda

Clinical Trial Manager

EOguda@kemri-wellcome.org+254748588041

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026