Target product profile for mild/moderate outpatient COVID-19

The ANTICOV consortium, led by DNDi, aims to identify treatments suitable for outpatient delivery to prevent the progression of mild or moderate COVID-19 to severe disease and spikes in hospitalizations that could overwhelm overburdened health systems in low-resource settings.

IdealAcceptable
IndicationFor treatment of non-severe and uncomplicated, symptomatic COVID-19 disease and clear the virus

This will not address potential other use for asymptomatic or contacts (this would require another TPP)
For treatment of non-severe and uncomplicated, symptomatic COVID-19 disease (with the intent to prevent progression to severe disease)

Complicated cases to be defined in an Appendix based on agreed criteria (WHO/ACT-A, ANTICOV Consortium)
Target population(s)Adults, pregnant and breastfeeding women, and children who are > 6 years

Can be treated as outpatients

Can be used in HIV+ patients (provided no DDI)
Adults

Can be treated as outpatients
Target countriesGlobalGlobal
Expected efficacy/ endpointsPrimary: decrease progression of disease vs SoC by 50% measured as SpO2 ≤ 93% at end of treatment

Secondary: improvement of pre-existing symptoms

Direct antiviral efficacy measured as a proportion of patients with negative respiratory swab on Day 7 after treatment initiation measured by RT-PCR
Primary: decrease progression of disease vs SoC by 50% measured as SpO2 ≤ 93% at end of treatment

Secondary: improvement of pre-existing symptoms
SafetyNo need for laboratory or ECG monitoring (including for treatment initiation)No need for systematic follow-up laboratory or ECG monitoring

Clinical benefit outweighs risks during active infection and transmission – SAEs are no higher than for SoC
CoadministrationCombination with other COVID-19 interventional agents not contraindicated (antibiotics, immunomodulators).Combination with other COVID-19 interventional agents not contraindicated (antibiotics, immunomodulators)
Contraindications, warnings, precautions, interactions, and use during pregnancy and lactationCould be co-administered in TB, HIV and malaria co-infected patients (no DDI with rifampicin)

Efficacy and safety in malnourished patients

Could be administered with antidiabetics, anti-hypertensive treatments
Cannot be administered in loa-loa patients (specific to ivermectin)
Route of administrationMultiple formulations – oral and pediatric formulationsOral tablet or capsule preferred

Sub-cutaneous or depot IM only if single dose treatment
Dosage form and scheduleOnce a day ≤ one week (including for children, adolescents)Up to 3x per day (oral) if limited to 3 days max

2x per day – up to 2 weeks max
Shelf-lifeFinished product stable for 5 yearsFinished product stable for 2 years
CostUnder 5 USD/regimenUnder 10 USD/regimen
StorageStore at room temperature (defined as 30 °C/75 % RH (zone IV B conditions)Store at room temperature (defined as 30 °C/75 % RH (zone IV B conditions)
Product registration pathLabel extension via AMA – WHO-PQLabel extension via AMA – WHO-PQ
Abbreviations: ACT-A : Advancing Cryptococcal Meningitis Treatment for Africa; AMA: American Medical Association; ASAQ: Artesunate + amodiaquine; DDI : drug-drug interactions; ECG: electrocardiogram; IM: intramuscular; PQ: Prequalification; RH: relative humidity; SAE: severe adverse effect; SoC : standard of care; SpO2 : peripheral capillary oxygen saturation; TB: tuberculosis; TPP: Target Product Profile; WHO: World Health Organization.