International ALLIANCE Study of Therapies to Prevent Progression of COVID-19

What Was Tested

In this phase 2 trial, researchers set out to test Cyanocobalamin (Vitamin B12).

COVID-19 is a global pandemic.

It had two arms (groups): Vitamin C (experimental) and Control (active comparator).

The registry classes the interventions as dietary supplement and drug.

More on the Plan

Expected number of participants The sample size for the study is a minimum of 100 participants in each arm.

However, this sample size may change as this trial has an adaptive design.

Allocation procedure Randomization: Eligible patients that have provided informed written consent will be randomized by independent researcher.

Randomization will be in randomly permuted blocks (undisclosed sizes to maintain concealment of allocation).

Who Took Part

Enrollment: 200 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age ≥ 18 years. Provision of informed consent in writing, can be electronic. Diagnosis of active COVID-19.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

Random assignment meant chance, not the researchers, decided who got Cyanocobalamin (Vitamin B12) and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received Cyanocobalamin (Vitamin B12).

Those kept unaware of assignments: investigator and outcomes assessor.

It started in 2020-09-09 with completion listed for 2021-09-30.

It ran at 1 site in Australia.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Symptoms (time frame: once daily for 15 days since enrollment/baseline at admission to hospital). Length of hospital stay (time frame: at 15 and 45 days since admission/ enrolment). invasive mechanical ventilation or mortality (time frame: any time within 15 days from enrolment).

It also tracked 8 secondary outcomes, for example Mortality, mechanical ventilation, oxygen, ICU, days in hospital and days in ICU.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Cyanocobalamin (Vitamin B12) in 200 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Cyanocobalamin (Vitamin B12) compound page, all human trials.