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Antiviral

Remdesivir for COVID-19 (CARAVAN Trial)

Phase 2 & 3
Waitlist Available
Research Sponsored by Gilead Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 2: end of infusion and 4 hours post end of infusion, day 3: pre-infusion and 2 hours post end of infusion, and day 5: middle of infusion and 6 hours post end of infusion; infusion duration: 30 minutes to 2 hours
Awards & highlights

CARAVAN Trial Summary

This trial will study the safety and effectiveness of the drug remdesivir in kids aged 0-18 who have been diagnosed with COVID-19.

Eligible Conditions
  • COVID-19
  • Coronavirus

CARAVAN Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 2: end of infusion and 4 hours post end of infusion, day 3: pre-infusion and 2 hours post end of infusion, and day 5: middle of infusion and 6 hours post end of infusion; infusion duration: 30 minutes to 2 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 2: end of infusion and 4 hours post end of infusion, day 3: pre-infusion and 2 hours post end of infusion, and day 5: middle of infusion and 6 hours post end of infusion; infusion duration: 30 minutes to 2 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
PK Parameter: AUCtau of Remdesivir and Its Metabolites GS-704277 and GS-441524 at Steady State
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
Percentage of Participants With Treatment-Emergent Graded Laboratory Abnormalities
+1 more
Secondary outcome measures
Bilirubin Concentrations in < 14-day-old Participants
Change From Baseline in Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Viral Load Up to Day 10 or Up to the First Confirmed Negative PCR Result
Days to First Confirmed Negative Polymerase Chain Reaction (PCR) Result
+7 more

Side effects data

From 2020 Phase 3 trial • 1062 Patients • NCT04280705
10%
Glomerular filtration rate decreased
9%
Haemoglobin decreased
8%
Lymphocyte count decreased
8%
Anaemia
7%
Respiratory failure
7%
Pyrexia
7%
Blood glucose increased
6%
Hyperglycaemia
6%
Blood creatinine increased
3%
Aspartate aminotransferase increased
2%
Cardiac arrest
2%
Septic shock
2%
Acute respiratory failure
2%
Lymphopenia
1%
Respiratory distress
1%
Acute respiratory distress syndrome
1%
Hypotension
1%
Shock
1%
Atrial fibrillation
1%
Multiple organ dysfunction syndrome
1%
Intestinal ischaemia
1%
Cerebrovascular accident
1%
Hypoxia
1%
Pneumonia aspiration
1%
Acute kidney injury
1%
Pneumothorax
1%
Pulmonary embolism
1%
Dyspnoea
1%
Endotracheal intubation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Remdesivir

CARAVAN Trial Design

8Treatment groups
Experimental Treatment
Group I: Remdesivir (RDV), Cohort 1: Age 12 to <18 Years and Weight ≥40 kgExperimental Treatment1 Intervention
Participants will receive RDV 200 mg, intravenous (IV) infusion on Day 1 followed by RDV 100 mg, IV infusion, daily, up to 10 days.
Group II: RDV, Cohort 8: < 12 Years and Weight ≥ 40 kgExperimental Treatment1 Intervention
Participants will receive RDV 200 mg, IV infusion on Day 1 followed by RDV 100 mg, IV infusion daily up to 10 days.
Group III: RDV, Cohort 7: Age 0 to < 56 Days of Age, Gestational Age ≤ 37 Weeks, and Birth Weight ≥ 1.5 kgExperimental Treatment1 Intervention
Participants will receive RDV 2.5 mg/kg, IV infusion on Day 1 followed by RDV 1.25 mg/kg mg, IV, daily, up to 10 days.
Group IV: RDV, Cohort 6: Age 0 to < 14 Days of Age, Gestational Age > 37 Weeks, and Birth Weight ≥ 2.5 kgExperimental Treatment1 Intervention
Participants will receive RDV 2.5 mg/kg, IV infusion on Day 1 followed by RDV 1.25 mg/kg mg, IV, daily, up to 10 days.
Group V: RDV, Cohort 5: Age ≥14 - <28 Days of Age, Gestational Age >37 Weeks, and Weight at Baseline ≥2.5 kgExperimental Treatment1 Intervention
Participants will receive RDV 5 mg/kg, IV infusion on Day 1 followed by RDV 2.5 mg/kg mg, IV infusion, daily, up to 10 days.
Group VI: RDV, Cohort 4: Age ≥ 28 Days to < 18 Years and Weight ≥ 3 kg to < 12 kgExperimental Treatment1 Intervention
Participants will receive RDV 5 mg/kg, IV infusion on Day 1 followed by RDV 2.5 mg/kg mg, IV infusion, daily, up to 10 days.
Group VII: RDV, Cohort 3: Age ≥ 28 Days to < 18 Years and Weight ≥ 12 kg to < 20 kgExperimental Treatment1 Intervention
Participants will receive RDV 5 mg/kg, IV infusion on Day 1 followed by RDV 2.5 mg/kg mg, IV infusion, daily, up to 10 days.
Group VIII: RDV, Cohort 2: Age ≥ 28 Days to < 18 Years and Weight ≥ 20 kg to < 40 kgExperimental Treatment1 Intervention
Participants will receive RDV 5 mg/kg, IV infusion on Day 1 followed by RDV 2.5 mg/kg mg, IV infusion, daily, up to 10 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Remdesivir
2020
Completed Phase 3
~21440

Find a Location

Who is running the clinical trial?

Gilead SciencesLead Sponsor
1,077 Previous Clinical Trials
837,494 Total Patients Enrolled
21 Trials studying COVID-19
18,964 Patients Enrolled for COVID-19
Gilead Study DirectorStudy DirectorGilead Sciences
341 Previous Clinical Trials
185,769 Total Patients Enrolled
9 Trials studying COVID-19
9,413 Patients Enrolled for COVID-19

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are being welcomed into this experiment?

"To move forward with the study, a total of 62 patients that pass the clinical trial's inclusion criteria are needed. The sponsor, Gilead Sciences, will be managing the trial from different locations including Children's Hospital of Alabama in Birmingham and NYC Health + Hospitals/Jacobi Medical Center in Bronx."

Answered by AI

Is this trial being conducted at a great number of locations within the state?

"Children's Hospital of Alabama in Birmingham, Alabama, NYC Health + Hospitals/Jacobi Medical Center in Bronx, New york, and Northwell Health-Cohen Children's Medical Center are all participating locations for this trial. An additional 17 hospitals are also included."

Answered by AI

Has this experiment been conducted before?

"AbbVie first sponsored a study on Remdesivir in 2020. This initial Phase 3 drug approval trial had 2900 participants and was conducted in 183 cities across 36 countries. As of today, there are 10 active studies being performed to research the effects of Remdesivir."

Answered by AI

Can you please tell me what other drug studies Remdesivir has been used in?

"Remdesivir was first studied at Island Health - Victoria General Hospital in 2020. As of now, there have been a total of 31 completed clinical trials. Out of the 10 active clinical trials, many are based in Birmingham, Alabama."

Answered by AI

What has Remdesivir been commonly used to treat in the past?

"Remdesivir is often given to patients that fall in the weight range of 3.5 kilograms to less than 40 kilograms. Additionally, this medication can be used to treat other conditions such as a low spo2 level, supplemental oxygen requirements, and hospitalization."

Answered by AI

Are recruitment efforts for this trial still underway?

"That is correct, the online information indicates that this study is still enrolling patients. The trial was initially posted on 7/21/2020 and has since been updated on 11/4/2022. Currently, 62 individuals are being sought from 17 different locations."

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
How old are they?
18 - 65
What site did they apply to?
St. Christopher's Hospital for Children
What portion of applicants met pre-screening criteria?
Did not meet criteria
~13 spots leftby Mar 2025