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NCT04488081RECRUITINGIRB Ready

I-SPY COVID-19 TRIAL: An Adaptive Platform Trial for Critically Ill Patients

(I-SPY_COVID)

Sponsored by QuantumLeap Healthcare Collaborative

Quick Self-Assessment

See if you qualify and express your interest

Preparing your pre-screening questions...
๐Ÿ“Š
1 of 1500 participants interested
0% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

The goal of this project is to rapidly screen promising agents, in the setting of an adaptive platform trial, for treatment of critically ill COVID-19 patients. In this phase 2 platform design, agents will be identified with a signal suggesting a big impact on reducing mortality and the need for, as well as duration, of mechanical ventilation.

Who Can Participate

Inclusion Criteria

Subjects must meet all of the following inclusion criteria to be eligible for participation in this study: A. Male or Female, at least 18 years old B. Admitted to the hospital and placed on high flow oxygen (โ‰ฅ6L by nasal cannula or mask delivery system) or intubated for the treatment of (established or presumed) COVID-19. C. Informed consent provided by the patient, LAR or health care proxy. D. Confirmation of SARS-CoV-2 infection by PCR or Rapid antigen testing for SARS- CoV-2 infection prior to randomization.

Exclusion Criteria

A. Pregnant or breastfeeding women (must be documented by a pregnancy test during hospitalization) B. History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent based on review of the medical record and patient history. C. Comfort measures only. D. Acute liver disease, or chronic liver disease with a Child-Pugh score greater than 11. E. Resident for more than six months at a

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

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Study Type

INTERVENTIONAL

๐Ÿ‘ฅ

Target Enrollment

1500 participants

โšง

Gender

ALL

๐Ÿข

Sponsor

QuantumLeap Healthcare Collaborative

Study Locations

Choose your preferred location or select flexible during enrollment

RECRUITING

Birmingham

Alabama

Location available
View Birmingham location page
RECRUITING

Davis

California

Location available
View Davis location page
RECRUITING

Irvine

California

Location available
View Irvine location page
RECRUITING

Long Beach

California

Location available
View Long Beach location page
RECRUITING

Los Angeles

California

Location available
View Los Angeles location page
RECRUITING

Los Angeles

California

Location available
View Los Angeles location page
ACTIVE_NOT_RECRUITING

Newport Beach

California

Location available
View Newport Beach location page
RECRUITING

San Francisco

California

Location available
View San Francisco location page
RECRUITING

Aurora

Colorado

Location available
View Aurora location page

๐Ÿ“ And 27 more locations available

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

๐Ÿ”’ Secure ยท ๐Ÿฅ Expert Care

Looking for COVID-19 Treatment in Birmingham?

Join others in Alabama exploring innovative treatment options through clinical research

COVID-19 Treatment Options in Birmingham, Alabama

If you're searching for COVID-19 treatment in Birmingham, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Birmingham, Davis, Irvine and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with COVID-19. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Alabama
Now Enrolling
Up to 1500 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for COVID-19?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for COVID-19

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This COVID-19 Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT04488081. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.