A Phase 2 Study to Evaluate Axatilimab for Hospitalized Participants With Respiratory Involvement Secondary to COVID-19

Inclusion Criteria: Type of Participant and Disease Characteristics -

1. Documented or confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)infection by an FDA-approved polymerase chain reaction test of nasopharyngeal swab orstool less than 72 hours before randomization
2. Hospitalized for COVID-19
3. Illness of any duration with at least 1 of the following:
4. Clinical assessment (evidence of rales/crackles on exam) and peripheral capillaryoxygen saturation less than or equal to 94% on room air, or
5. Requiring mechanical ventilation and/or supplemental oxygen, or
6. Radiographic evidence (chest x-ray or computed tomography scan) of 1 of thefollowing:

• Ground-glass opacities, or
• Local or bilateral patchy infiltrates, or
• Interstitial pulmonary infiltrates

4. If the participant was intubated, must have been intubated less than 24 hours prior torandomization Sex and Contraception Guidelines -
5. Contraceptive use by men or women should have been consistent with local regulationsregarding the methods of contraception for those participating in clinical studies. Informed Consent -
6. Capable of giving signed informed consent or by a designated representative, whichincludes compliance with the requirements and restrictions listed in the informedconsent form and in this protocol

Exclusion Criteria: Medical Conditions -

1. Active bacterial pneumonia defined: based on either lobar consolidation on x-ray,positive sputum cultures, or leukocytosis with a left shift
2. Known active tuberculosis
3. Participants with acquired immune deficiency syndrome
4. It is not in the best interest of the participants to participate, in the opinion ofthe treating Investigator.
5. In the opinion of the investigator, progression to death was imminent and inevitablewithin the next 24 hours, irrespective of the provision of treatments.
6. Female participants who were pregnant or breastfeeding or expecting to conceive withinthe projected duration of the study, starting with the screening visit through 90 daysafter the last dose of study intervention Excluded Prior/Concomitant Therapy -
7. Prior treatment with other agents with actual or possible direct actinganti-inflammatory activity against SARS-CoV-2 in the past 30 days (for example,chloroquine, hydroxychloroquine)
8. Treatment with convalescent plasma
9. Treatment with high doses of corticosteroids (greater than 20 milligrams daily,prednisone equivalent) prior to randomization
10. Treatment with immunomodulators including anti-interleukin (IL)-6, anti-IL-6 receptorantagonists, or with Janus kinase inhibitors in the past 30 days or plans to receiveduring the study period
11. Previous exposure to study intervention or any other agent targeting colonystimulating factor-1 or CSF-1R or known allergy/sensitivity to study intervention