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COVID-19Phase 1NCT03891420

A Study to Evaluate the Safety, Pharmacokinetics and Antiviral Effects of Galidesivir in Yellow Fever or COVID-19

A Phase 1 study testing Galidesivir in people with COVID-19 and Yellow Fever, run by BioCryst Pharmaceuticals at 5 sites in Brazil.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a placebo-controlled, randomized, double-blind study to evaluate the pharmacokinetics, safety and antiviral activity of galidesivir in subjects with yellow fever (YF) or COVID-19. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
COVID-19, Yellow Fever
What is being tested?
Galidesivir
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
24 participants
Where
5 sitesBrazil
Study dates
9 Apr 2020to 30 Apr 2021
Phase
Phase 1
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Ability to provide written informed consent
  • Males and nonpregnant, non-breast-feeding females, aged 18 years or older
  • Subject weight ≥ 50 kg (110 lb.)
  • Positive test for YFV by molecular amplification of the virus in the blood
  • First onset of symptoms of YF occurring within the previous 7 days
  • Male and female subjects must agree to the contraception requirements and must meet the inclusion criteria regarding contraception as outlined in the protocol
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  • CLCR of at least 60 mL/min by Cockcroft-Gault equation
  • AST < 5000 u/L
  • Indirect bilirubin < 1.5 mg/dL
  • Neutrophil count < 7500 /mm3
  • International Normalized Ratio (INR) < 1.5
  • Ability to provide written informed consent, accept randomization to any assigned treatment arm, and comply with planned study procedures
  • Males and nonpregnant, non-breast-feeding females, aged 18 years or older
  • Male and female subjects must agree to the contraception requirements and must meet the inclusion criteria regarding contraception as outlined in the protocol
  • Subject weight ≥ 50 kg (110 lb.)
  • Clinical syndrome consistent with moderate-severe (but not critically ill) COVID-19, defined by at least one of the following:
  • Symptoms of acute viral lower respiratory tract infection, such as fever, non-productive cough, dyspnea, and either 1) a pulse oximetry oxygen saturation (SpO2) ≤ 94% or a respiratory rate > 24 breaths/minute as measured at rest without use of supplemental oxygen or 2) a clinical requirement for supplemental oxygen treatment or non-invasive mechanical ventilation
  • Radiographic pulmonary findings seen on chest imaging (chest X-ray or computed tomography [CT scan]) consistent with COVID-19
  • Positive test for SARS-CoV-2 by molecular amplification of the virus in a respiratory specimen (nasopharyngeal, oropharyngeal, lower respiratory tract [eg, expectorated sputum]) collected < 96 hours prior to randomization. Note: subjects may have a positive test recorded prior to screening if they are admitted to the hospital with a presumed case of COVID-19

Who cannot join

  • Any clinically significant medical condition or medical history that, in the opinion of the investigator or sponsor, would interfere with the subject's ability to participate in the study or increase the risk of participation for that subject
  • Employment by the study site, or an immediate family relationship to either study site employees or Sponsor employee
  • Lack of suitable veins for venipuncture/cannulation as assessed by the Investigator at Screening
  • Participation in any other investigational drug or vaccine study currently or within the past 30 days
  • Diagnosis of YF vaccine-related viscerotropic disease
  • Subjects with hepatic encephalopathy as defined by Conn Score ≥ 1.
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  • Subject has severe immunosuppression or immunodeficiency, leukemia, lymphoma, thymic disease, generalized malignancy, or radiation therapy (within the past 3 months), or is undergoing current treatment with immunosuppressive drugs, defined as drugs that impair immune responses to infections
  • A treatment plan for YF that would include concomitant administration of antiviral medications
  • Any clinically significant medical condition or medical history that, in the opinion of the investigator or sponsor, would interfere with the subject's ability to participate in the study or increase the risk of participation for the subject
  • Lack of suitable veins for venipuncture/cannulation as assessed by the Investigator at Screening
  • Participation in any other investigational drug or vaccine study currently or within the past 30 days
  • A clinical treatment plan that would include concomitant administration of any other experimental treatment or off-label use of marketed medications that are intended as specific treatment for the COVID-19 clinical syndrome or the SARS-CoV-2 infection. Any such medications must be discontinued prior to study enrollment, unless a formal written standard of care policy document from the national, state, or institutional authorities requires otherwise.
  • Severe or rapidly progressive disease or medical condition of any type such that death is an expected or likely outcome within 72 hours or that would require referral or transfer to another medical facility
  • Severe renal impairment (estimated glomerular filtration rate (eGFR) ≤ 50 mL/min/1.73m2) or receiving continuous renal replacement therapy, hemodialysis, or peritoneal dialysis
  • Severe liver disease by medical history or ALT or AST > 5 times upper limit of normal
  • Congestive heart failure by medical history ≥ Class 3
  • Requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) at the time of randomization

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Brazil5 sites

  • Hospital de Clinicas da Universidade Federal do Parana

    Curitiba, Paraná

  • Hospital Sao Vicente de Paulo-PPDS

    Passo Fundo, Rio Grande do Sul

  • Hospital Sao Lucas da Pucrs

    Porto Alegre, Rio Grande do Sul

  • Foundation Regional Faculty of Medicine of São José do Rio Preto

    São José do Rio Preto, São Paulo

  • Clinical Research Unit and Department of Infectious and Parasitic Diseases Hospital das Clínicas, School of Medicine, USP

    São Paulo, São Paulo, 05403-010

Other trials in Brazil

About this study

Official title: A Phase 1b Double-blind, Placebo-controlled, Dose-ranging Study to Evaluate the Safety, Pharmacokinetics, and Anti-viral Effects of Galidesivir Administered Via Intravenous Infusion to Subjects With Yellow Fever or COVID-19

This is a placebo-controlled, randomized, double-blind study to evaluate the pharmacokinetics, safety and antiviral activity of galidesivir in subjects with yellow fever (YF) or COVID-19.

Read the detailed description

This is a randomized, double-blind, placebo-controlled study to evaluate the pharmacokinetics (PK), safety, and antiviral effects of galidesivir administered via intravenous (IV) infusion vs. placebo in hospitalized adult subjects with either Yellow Fever (Group A) or COVID-19 (Group B). The study will be conducted in two parts, and each Group (A or B) will proceed independently through the study. Part 1 is a dose ranging study with three sequential cohorts of eight patients each that will be randomized 3:1 to receive IV galidesivir or placebo every 12 hours for 7 days. Upon completion of part 1, an optimized dosing regimen of galidesivir will be selected for part 2, based on part 1 results including safety, PK, viral load reduction, and improvement in signs and symptoms and clinical manifestations, and mortality. In part 2, up to 42 patients will be randomized 2:1 to receive IV galidesivir or placebo. After treatment, the patients will remain hospitalized until resolution of symptoms allows release. All patients will be followed for mortality through Day 56.

Being tested
Galidesivir, Placebo
Keywords
COVID-19, Galidesivir, Yellow Fever
Medical subject headings
COVID-19, Yellow Fever

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GalidesivirDrug

    Galidesivir IV infusion

  • PlaceboDrug

    Placebo IV infusion

Study groups in NCT03891420
Study groupRoleWhat they receive
GalidesivirExperimentalGalidesivir IV infusion
Receives: Drug: Galidesivir
PlaceboPlacebo comparatorPlacebo IV infusion
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. number of subjects with treatment emergent adverse events and serious adverse events

    Measured: absolute number through the end of the study, approximately 56 days

  2. number of subjects with change in laboratory parameters

    Measured: absolute number and change from baseline through the end of the study, approximately 56 days

  3. exposure of galidesivir as measured by plasma concentrations

    Measured: 24 hours post dose on Day 1 through 12 hours post dose on Day 7

Secondary outcomes (5)

  1. yellow fever virus (YFV) titer (Group A)

    Measured: change in YFV titer from baseline through Day 21

  2. antiviral effect on SARS-CoV-2 in the respiratory tract - COVID-19 (Group B)

    Measured: change in SARS-CoV-2 from baseline through Day 21

  3. changes in clinical status using 8-point ordinal scale in COVID-19 (Group B)

    Measured: through Day 21

  4. changes from baseline and time to improvement using NEWS in COVID-19 (Group B)

    Measured: through Day21

  5. mortality

    Measured: mortality at Day 56

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2019
  2. Study start9 Apr 2020
  3. Primary completion31 Jan 2021
  4. Study completion30 Apr 2021

Why it stopped: Sponsor decision to no longer pursue indications studied in this trial

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03891420
Sponsor's protocol ID
BCX4430-108
Other IDs
272201300017C-18-0-1, DMID18-0022
Status last verified
May 2021
First submitted
15 Mar 2019
Last updated
27 May 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Galidesivir in people with COVID-19 and Yellow Fever, run by BioCryst Pharmaceuticals at 5 sites in Brazil.

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 19 inclusion and 17 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: stopped early, as of the sponsor's last update on 27 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Brazil. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Sponsor decision to no longer pursue indications studied in this trial). Results are not available in the source record.

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?

number of subjects with treatment emergent adverse events and serious adverse events (time frame: absolute number through the end of the study, approximately 56 days). The study lists 3 primary outcomes in all. 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 NCT03891420.

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 27 May 2021.

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