CLINICAL TRIAL

MIB-626 for Covid19

Stage I
Recruiting · 18+ · All Sexes · Boston, MA

Phase 2a MIB-626 vs. Placebo COVID-19

See full description

About the trial for Covid19

Eligible Conditions
Covid19 · Stage 1 Acute Kidney Injury · COVID-19 · Acute Kidney Injury

Treatment Groups

This trial involves 2 different treatments. MIB-626 is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
MIB-626
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Placebo
DRUG

Eligibility

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
I am not pregnant and I am not planning to become pregnant over the next 6 months. show original
The person is able to consent or has a legal representative consenting on their behalf after being given all information needed. show original
Patients will be randomized if they have a confirmed SARS-CoV-2 infection by an approved diagnostic test. show original
to her/him The participant or legal representative has read and signed the Informed Consent Form (ICF) after being fully informed of the nature of the study. show original
, may marry A person aged 18 or over may marry. show original
I'm currently hospitalized show original
The patient's serum creatinine level increased by 0.3 mg/dL or by 50% to 99% over their baseline levels. show original
The individual is able to authorize the use and disclosure of personal health information in accordance with the Health Insurance Portability and Accountability Act (HIPAA). show original
Patients who are receiving remdesivir as a part of their clinical care or are in clinical trials of remdesivir or other antiviral drugs may be allowed if they meet other eligibility criteria
Patients, who are participating in observational studies or studies of nonpharmacological interventions, will be allowed to participate
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: enrollment to 14 days or hospital discharge, or death, whichever comes first
Screening: ~3 weeks
Treatment: Varies
Reporting: enrollment to 14 days or hospital discharge, or death, whichever comes first
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: enrollment to 14 days or hospital discharge, or death, whichever comes first.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether MIB-626 will improve 1 primary outcome, 10 secondary outcomes, and 8 other outcomes in patients with Covid19. Measurement will happen over the course of enrollment to 14 days or hospital discharge, or death, whichever comes first.

The number and proportion of patients who die
ENROLLMENT TO 14 DAYS OR HOSPITAL DISCHARGE, OR DEATH, WHICHEVER COMES FIRST
The number and proportion of patients who die
ENROLLMENT TO 14 DAYS OR HOSPITAL DISCHARGE, OR DEATH, WHICHEVER COMES FIRST
Progression in the stage of acute kidney injury increase in serum creatinine OR serum creatinine > 4.0 mg/dL OR need
ENROLLMENT TO 14 DAYS OR HOSPITAL DISCHARGE, OR DEATH, WHICHEVER COMES FIRST
Progression in the stage of acute kidney injury
ENROLLMENT TO 14 DAYS OR HOSPITAL DISCHARGE, OR DEATH, WHICHEVER COMES FIRST
Change from baseline in serum cystatin C levels
ENROLLMENT TO 14 DAYS OR HOSPITAL DISCHARGE, OR DEATH, WHICHEVER COMES FIRST
Change from baseline in serum cystatin C levels
ENROLLMENT TO 14 DAYS OR HOSPITAL DISCHARGE, OR DEATH, WHICHEVER COMES FIRST
Change from baseline in markers of microvascular thrombosis (D-dimer, fibrinogen)
ENROLLMENT TO 14 DAYS OR HOSPITAL DISCHARGE, OR DEATH, WHICHEVER COMES FIRST
Change from baseline in markers of microvascular thrombosis (D-dimer, fibrinogen)
ENROLLMENT TO 14 DAYS OR HOSPITAL DISCHARGE, OR DEATH, WHICHEVER COMES FIRST
Change from baseline in markers of endothelial damage (vWF, VCAM, PAI-1)
ENROLLMENT TO 14 DAYS OR HOSPITAL DISCHARGE, OR DEATH, WHICHEVER COMES FIRST
Change from baseline in markers of endothelial damage (vWF, VCAM, PAI-1)
ENROLLMENT TO 14 DAYS OR HOSPITAL DISCHARGE, OR DEATH, WHICHEVER COMES FIRST
Change in urinary albumin concentration (normalized to urine creatinine) from enrollment to peak during hospitalization
ENROLLMENT TO 14 DAYS OR HOSPITAL DISCHARGE, OR DEATH, WHICHEVER COMES FIRST
Change in urinary albumin concentration (normalized to urine creatinine) from enrollment to peak during hospitalization
ENROLLMENT TO 14 DAYS OR HOSPITAL DISCHARGE, OR DEATH, WHICHEVER COMES FIRST
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Who is running the study

Principal Investigator
S. B.
Shalender Bhasin, Principal Investigator
Metro International Biotech, LLC

Patient Q & A Section

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

What are common treatments for covid19?

There is a large scope of treatment options available for patients with covid19, ranging from symptomatic symptom- management to specific antiviral and anti-rabies vaccines. Most of the available treatment options are in the context of public health interventions.

Anonymous Patient Answer

What is covid19?

This pandemic is a health crisis for those who have compromised immune systems from diseases such as HIV or chronic illnesses, as well as elderly people that lack adaptive immunity.\n

Anonymous Patient Answer

Can covid19 be cured?

Covid19 is contagious, but there are some indications that immunity to the virus may occur; these need to be examined in the future. The possibility exists, thus, for an eventual cure.

Anonymous Patient Answer

How many people get covid19 a year in the United States?

1 in 100,000 - 106,000 Americans are infected with Covid19, in this time frame. There may be as many as 20,000 hospitalizations and over 1,000 deaths annually in the United States. It is clear that much more will be ascertained as we move forward with investigation.

Anonymous Patient Answer

What causes covid19?

Covid19 may be related to human factors such as environmental and personal factors. Though the cause and severity of the epidemic remain unknown, these results could help inform international initiatives and interventions to prevent and treat outbreaks.

Anonymous Patient Answer

What are the signs of covid19?

Signs of coronavirus include fever, headaches, a cough, muscle and/or joint pains, gastrointestinal problems, and swelling in the lungs, which can quickly worsen. These signs can occur within 2 days of contracting the coronavirus or within 15 days.

Anonymous Patient Answer

Does covid19 run in families?

The current studies suggest an additive genetic contribution of CVD risk factors to susceptibility to COVID-19, which may be determined genetically. Furthermore, we hypothesize that familial COVID-19 disease may have a different clinical course, although further studies are necessary to confirm this finding.

Anonymous Patient Answer

What is mib-626?

Mib-626 was not a candidate to be a first-in-class antiviral candidate. The candidate A-3G/A02-001 was also found to have activity against SARS coronavirus. Additionally, a candidate vaccine for Middle East respiratory syndrome-related coronavirus 2 (MERS-CoV) (AUR01) was found. Results from a recent clinical trial are important for the global health and pharmaceutical industry because other SARS and MERS-CoV-related coronaviruses are projected to spread out of their geographic regions.

Anonymous Patient Answer

What are the common side effects of mib-626?

Results from a recent paper suggests that only a minority of patients develop the expected side effects of mib-626 injections, and even then these side effects are mainly transient.

Anonymous Patient Answer

Who should consider clinical trials for covid19?

For the general public, a combination of evidence regarding the effectiveness, safety, and availability, with cost considerations related to clinical trials, should provide a basis for informed decision-making regarding their use in a clinical case.

Anonymous Patient Answer

What does mib-626 usually treat?

Mib-626 treats many conditions involving the skin and respiratory tracts that have been diagnosed as idiopathic in nature. All of the conditions evaluated are considered common in patients with mib-626.

Anonymous Patient Answer

What is the latest research for covid19?

There are no licensed treatments for the general public, and the general public is advised to take care of their body and take regular breaks from exercise. Furthermore, the general public should avoid prolonged contact with infected people, but the current situation may not be so serious that it is important to know where to go to ask for assistance and how to get advice and help. The general public is asked to follow the advice from local authority on where to go if there are any concern or discomfort, and to make sure to tell a doctor as soon as is possible after getting infected with the coronavirus.

Anonymous Patient Answer
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