A Phase 1/2 interventional study of Azithromycin and Sunitinib and Erlotinib in Ebola Virus Disease, sponsored by Clinical Research Management, Inc.. Status unknown. Open to participants aged 6 Months and older. Per ClinicalTrials.gov, last updated 2015-03-05.
Sponsored by Clinical Research Management, Inc. · Phase 1/2, Interventional, and Treatment
The purpose of this study is to determine whether multiple therapeutic regimens are effective in the treatment of Ebola Virus Disease (EVD)
The ongoing epidemic of EVD has ravaged parts of West Africa, with initial cases reported in December 2013. There is no licensed specific therapy for the disease, which has a case-fatality rate of approximately 50-70%. Although anecdotal clinical data, recent studies in animal models, and in vitro screening suggest that treatment of EVD patients with anti-viral agents, immune modifying agents, and/or convalescent blood products may be effective, they have not been evaluated in clinical trials. This multi-arm clinical trial will evaluate the efficacy and safety of multiple regimens, both as mono-therapy and combination therapy. Provision of these regimens, if found effective and safe, would have a major impact on the current and future epidemics by providing effective treatment options.
As described for previous adaptive trials, a randomization probability for each of the treatment regimens is created based on 14-day mortality, and is used for weighting randomization of subsequently enrolled participants. Participants will continually be preferentially assigned to regimens with better initial performance. New agents can be added or existing agents removed as the trial evolves.
914 studies on the registry are indexed under Virus Diseases; 110 are open to participants now.
This study's planned enrollment of 150 is above the median of 102 across 604 interventional studies indexed under Virus Diseases.
Browse Virus Diseases studies →Clinical Research Management, Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Azithromycin, IV fluids and laboratory testing
Drug: Azithromycin · Other: IV fluids and laboratory testing
Sunitinib, Erlotinib, IV fluids and laboratory testing
Drug: Sunitinib and Erlotinib · Other: IV fluids and laboratory testing
Atorvastatin, Irbesartan, IV fluids and laboratory testing
Drug: Atorvastatin and Irbesartan · Other: IV fluids and laboratory testing
no additional treatment
Other: IV fluids and laboratory testing
Adults (\>18 yrs): 3 x 500mg tablets daily for 5 days; Children (6 months to \<18 yrs): 30mg/kg (oral suspension) daily for 5 days
Also known as: Zithromax
Sunitinib - Adults (\>18 yrs): 1 x 50mg tablet daily for 7 days; Children (6 months to \<18 yrs): 0.83 mg/kg (oral suspension) daily for 7 days. Erlotinib - Adults (\>18 yrs): 1 x 150mg tablet daily for 7 days; Children (8kg to \<20kg): 3.5 mg/kg daily for 7 days; Children (\>20kg to \<30kg): 3.0 mg/kg daily for 7 days; Children (\>30kg to \< 18 yrs): 25 mg/kg daily for 7 days
Also known as: Sutent, Tarceva
Atorvastatin - Adults (\>18 yrs): 1 x 40mg tablet daily until discharge; Children (6 years to \<18 yrs): 1 x 40mg tablet daily until discharge; Irbesartan - Adults (\>18 yrs): 1 x 150mg tablets daily until discharge; Children (6 years to \<18 yrs): 1 x 75mg tablet daily until discharge.
Also known as: Lipitor, Avapro
All arms will receive aggressive IV fluid rehydration and frequent laboratory tests to assist with medical management as indicated.
Death by 14 days
Time frame: 14 days after starting treatment regimen
Reduction in viral load
Time frame: 14 days after starting treatment regimen
2-week post discharge clinical sequelae, including signs and symptoms and laboratory abnormalities
Time frame: 14 days after starting treatment
Severe adverse events that are inconsistent with EVD and are assessed as related to study agent(s) by the site principal investigator
Time frame: 14 days after starting treatment
No study locations are listed for this record.
This study is status unknown, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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Clinical Research Management, Inc.